Iqvia Institute Spotlight On Biosimilars

Spotlight on
Biosimilars
OPT IMISING THE SUS TA INABILI T Y
OF HE ALTHC ARE S YS TEMS
JUNE
2021
Introduction
Competition from biosimilars has the potential to improve patient access
to biologic therapies, balance spending, and unlock savings for innovation.
However, while progress has been made since our first report on the subject
(Advancing Biosimilar Sustainability, 2018), the benefits still do not meet their
full potential.
This report highlights the progress made by healthcare systems (as of April
2021), using case studies from a selection of European countries ranging from
large to small, national to regional systems, as well as suggestions for what
should be optimised using our comprehensive and well-established framework
for assessing biosimilar sustainability.
Different stakeholders — from policy makers through to patients — and their

roles are considered. Examples are used throughout to highlight successful
programmes that can be incorporated by others, and the barriers that
can be overcome.
This report has been developed independently by the Find Out More
IQVIA Institute for Human Data Science, drawing on
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across selected European countries. Their contributions
to this report are gratefully acknowledged. Funding for
this research and report has been provided by Biogen.
The findings and statements in the report, including MURRAY AITKEN
the interviewees’ views expressed in quotes, are not Executive Director
necessarily those of Biogen. IQVIA Institute for Human Data Science
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Table of contents
Overview 2
The importance of ‘sustainability’ in markets for biosimilars 3
Current trends in patient access to biologic therapies 7
Pillars and pitfalls for sustainability in European biosimilar markets 9
Transitioning to practices that create sustainable markets for biosimilars 12
Notes on sources 17
Methodologies 18
References 19
Appendix - The sustainability of regional healthcare systems 20
Assessment of Austria 20
Assessment of France 22
Assessment of Lombardy, Italy 24
Assessment of Puglia, Italy 26
Assessment of Sicily, Italy 28
Assessment of Poland 30
Assessment of Andalusia, Spain 32
Assessment of Navarra, Spain 34
Assessment of Catalonia, Spain 36
About the authors 38
About the Institute 39

Overview
of expiry totalling over $40 billion. With the volume
The global biologic medicines market is currently and type of molecules expected to lose exclusivity,
valued at $320 billion in 2020 and accounts for almost there is a need to optimise systems. Countries benefit
one third of the global market for pharmaceuticals by from an independent view on the current system, and
value. In Europe, biologic molecules account for 40% the creation of easily implementable plans to reap the
of the total market value in 2020, and new launches full benefits in anticipation of the biologic bubble. This
are expected to increase from 13 new molecules per report highlights examples of the benefits biosimilar
year (2014–2018) to 27 per year (2021–2025). Managing competition can create, as well as how these benefits
this segment, and its growth, therefore becomes a can be unlocked through optimisation.
necessary part of sustainable healthcare systems.
In this report, the sustainability of the biosimilar
The concept of ‘biosimilar sustainability’ has therefore marketplace was assessed across a set of five
become increasingly important for all stakeholders European markets with a broad spectrum of systems
to understand, and was advanced in 2018 as an and approaches. A set of four biologic medicines, and a
approach to deliver on the promise of biosimilars. structured sustainability framework made of 9 metrics
Fundamentally, biosimilar entry stimulates competition was used to determine examples of sustainable
within an established therapy area which has the practices, and areas for system optimisation that
impact of reducing prices, allowing for more patients can be used across European healthcare systems.
to be treated with biologic therapies, earlier treatment The studied markets have a mix of national (Austria,
of patients due to reduced costs, savings for additional France, Poland), and regional systems in three Italian
services, and reinvestment in future innovative regions (Lombardy, Sicily, Puglia), and three Spanish
medicines. regions (Andalusia, Catalonia, Navarra) to offer a range

of granular insights.
In the short-term (2021-2023) the European market
To date, progress has been in many markets towards
provides a relatively low opportunity for biosimilars
sustainable practices. However, our study of these
with only a small number of brands losing exclusivity.
markets revealed the following three themes as the
However, this will change dramatically between 2024
most common hurdles to biosimilar sustainability:
and 2029 as approximately 100 biologic medicines will
unsustainable purchasing policies for the procurement
lose exclusivity with a forecast sales value in their year
of biologics; limited tangible benefits offered to
prescribers to encourage the use of biosimilars; and
lack of physician and patient education on biosimilars.
Although many of the best practice approaches that

It is in the best interests of all support biosimilar sustainability are already present
stakeholders to learn from the somewhere in Europe, they are not consistently
implemented in every country. As each country has a
issues that have arisen, gather unique policy footprint and has started from different
perspectives from other countries, positions, the journey towards a sustainable market is
and implement targeted approaches therefore different for each individual market. It is in
the best interests of all stakeholders to learn from the
for their individual markets that issues that have arisen, gather perspectives from other
will work into the future to optimise countries, and implement targeted approaches for
their individual markets that will work into the future
the system, and unlock the full
to optimise the system, and unlock the full benefits of
benefits of biosimilars. biosimilars.
2 | Spotlight on Biosimilars: Optimising the Sustainability of Healthcare Systems

The importance of MANAGING THE INTRODUCTION OF BIOSIMILARS
BECOMES INCREASINGLY CRITICAL
‘sustainability’ in markets In a European context, biologic molecules account
for biosimilars for 40% of the total market value in 2020. While this
varies in European countries, the expenditure on
BIOLOGIC MEDICINES ARE A SIGNIFICANT innovative biologic medicines ranges from 15% and
AND GROWING SEGMENT 41% (at list prices, excluding rebates and discounts) of
The global biologic medicines market is currently total pharmaceutical spend. Managing this segment,
valued at $320 billion in 2020 (see Exhibit 1) and and its growth, therefore becomes a necessary part of
accounts for almost one third of the global market for sustainable healthcare systems.
pharmaceuticals by value. This figure continues to grow
at a significant pace with a 5-year CAGR of 9.5%. In The 79 biosimilar medicines now authorised in Europe
2020 alone, over 55% of the growth in pharmaceutical play a critical role in driving more sustainable healthcare
expenditure (at list prices, excluding rebates and systems.2 Biosimilars represent only 4% of the total
discounts) in 2020 is attributable to innovative biologics. European pharmaceutical market by value, but they play
a bigger role in the accessible market by stimulating
This is not a short-term trend as expenditure on competition. The accessible market refers to markets
innovative biologics is forecast to grow based on where originator medicines have lost their protection
a robust drug development pipeline. Biologics will status and have a biosimilar available. Biosimilars account
increase their share of global new active substance for 14% within the accessible market, but their presence
(NAS) launches, increasing from approximately 13 has an impact on the other 86% of the market through
new molecules per year (in the period 2014-2018) competition (see Exhibit 2). Biosimilar competition has
to 27 per year (2021–2025). Biologic medicines are
1
an impact on price, increases the security of supply,
currently used in an increasing number of therapy improves patient access to biologic therapies, and
classes and are expanding into traditionally primary has additional system-wide benefits if it is leveraged
care conditions such as anti-infectives, heart failure, effectively. This underscores the vital importance of
migraine, pain, and respiratory. biosimilars to healthcare systems.
Exhibit 1: Increasing Importance of the Biologic Medicines Market
Overview of the global pharmaceutical market split by biologic medicines (2020, US$)
1.2 100%
1.1 90%
1.0
Late stage pipeline breakdown
80%
0.9
70%
0.8
0.7 60%
USD Trn
0.6 50%
0.5 40%
0.4
30%
0.3
20%
0.2
0.1 10%
0.0 0%
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
Biologic medicines Other medicines

Source: IQVIA MIDAS ® Q4 2020, IQVIA Institute analysis using Pipeline Intelligence
Exhibit Notes: Biologic medicines are defined as innovative biologic molecules and innovative biologics. Other medicines category includes innovative
small molecules and generics.
iqviainstitute.org | 3
Exhibit 2: Biosimilars as a Portion of the Accessible Biologics Market
European biosimilar share within the accessible market (treatment days, absolute value, % market share)
6,000
14%
5,000
4,000
3,000 2020
2,000
1,000 86%
0
2015 2016 2017 2018 2019 2020
Biosimilar Biosimilar accessible market (ex. biosimilars)

Source: IQVIA Impact of Biosimilar Competition Report 2020
Exhibit Notes: Accessible market includes referenced medicines and non-referenced medicines across major therapy areas available for biosimilar
competition. Therapy areas include GCSFs, EPO, HGH, fertility, insulins, LLMWHs, anti-TNFS, oncology.
FURTHER BIOLOGIC LOSS OF EXCLUSIVITY IS opportunity for biosimilars with only a small number
NOT IMMEDIATE of brands losing exclusivity. From 2024 to 2029, this
By 2025, $112 billion of biologic medicines will lose dramatically increases as approximately 100 biologic
exclusivity in the global market. This figure has medicines will lose exclusivity with a forecast sales
doubled since 2018, and is driven by the prospect of value in their year of expiry totalling over $40 billion.
major losses of exclusivity (LoE), notably adalimumab
Europe is therefore entering a period where there
(Humira) in the US. 3
are no major LoE events offering savings in the short-
In a European context, the forecast offers different term. The EU systems are required to urgently review
insights. Europe has already had major LoE events their progress to date, and optimise their system for
such as adalimumab, trastuzumab, and bevacizumab. implementing biosimilar competition at scale
The next 3 years (2021–2023) provide a relatively low (see Exhibit 3).
Exhibit 3: Forecast Potential for Biosimilar Competition in Europe
40 Establishment and testing Optimisation and preparation Implementation at scale 70

Unique loss of exclusivity during period
35 60
Biologic loss of exclusivity
30
(sales, 2012-2029, € Bn)
50
25.3
25
40
20 17.1
30
15
20
10 7.8
6.8
4.4 4.3 10
5
0 0
2012-2014 (a) 2015-2017 (a) 2018-2020 (a) 2021-2023 (f) 2024-2026 (f) 2027-2029 (f)
Value of LoEs Number of LoEs
Source: IQVIA MIDAS Q4 2020, IQVIA ForecastLink data for post-2020 period, Rx biologics in 23 European markets
®
Exhibit Notes: (a) represents actual sales, (f) = forecast sales. The IP for biologicals can include multiple patents and patent timelines for each individual
product and therefore it is difficult to give an exact date for patent expiry of biologics. It should be noted that these results are estimates as determined
by IQVIA MIDAS ® and ARK Patent Intelligence where available.

Notably, pembrolizumab (Keytruda) and nivolumab
(Opdivo) are expected to lose exclusivity in the longer-
term horizon, alongside 14 other high-value biologics.4 The European Commission’s
However, the majority of LoEs in this period are orphan
new ‘Pharmaceutical Strategy
medicines, or are for conditions managed by specialists
with limited familiarity with biosimilars. Some countries
for Europe’ aims to support
are further on the journey to sustainable practices and foster further competition,
and are preparing to leverage biosimilar competition
innovative capacity, and
within markets at scale. It is in the best interests of
all stakeholders to gather perspectives from other sustainability.
countries, learn from the issues that have arisen, and
implement approaches that will work into the future. necessity to emphasize the high quality of biosimilars
and achievable savings, often highlighting that
SUSTAINABILITY IN A HEALTHCARE CONTEXT
authorities and payers are focused mostly on savings,
‘Sustainability’ in a healthcare context is a journey in
with other factors (patient access, level of supply)
which, ideally, all stakeholders within a market can
being less of a priority.6 The long-term sustainability of
function effectively. It is the creation of a system that
a marketplace is an important concept to understand
benefits all stakeholders, focussing on the patient,
for all stakeholders in the healthcare system, given the
and ultimately ensures the longevity of a system. The
increasing importance of biologics, and of leveraging
concept of ‘biosimilar sustainability’ was advanced
in 2018 as an approach to deliver on the promise biosimilar competition.
of biosimilars. They can balance pharmaceutical

European policy makers are also prioritising access
spending; unlock savings for future innovation; and
to biosimilars and sustainability. The European
ultimately improve access to biologic therapies5
Commission’s new ‘Pharmaceutical Strategy for Europe’,
through competition.
published in November 2020, aims to support and
Experts —
from policy makers to clinicians — agree foster further competition, innovative capacity, and
with the definition (see Exhibit 4), and mention the sustainability within the EU’s pharmaceutical industry.7
Exhibit 4: Definition of ‘Biosimilar Sustainability’
Patient access
Biosimilar sustainability improves patient

Physician prescription choice
access and physician prescription choice of
Safety and high-quality biologics
safe and high-quality biologic medicines, in
a framework that considers the needs of all
Needs of all stakeholders stakeholders (patients, healthcare
professionals / providers, and manufacturers),
Healthcare budgets
provides a means to manage existing
healthcare budgets while safeguarding a
Healthy level of competition
healthy level of competition and supply.
Healthy level of supply
Source: IQVIA Institute for Human Data Science, Advancing Biosimilar Sustainability in Europe, 2018
Exhibit 5: Cumulative Patient Treatment Days for EU-Approved Biosimilar Medicines
2,400
2,200 2.2 Bn >800 Mn
patient days with EU-approved patient treatment
Cumulative treatment days (Mn)
2,000
biosimilar medicines days provided
1,800 by biosimilar
1,600 manufacturers
between 2019
1,400 and 2020 alone
1,200
1,000
800
600
400
200
0
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Source: IQVIA MIDAS ® Q4 2020 data

Exhibit Notes: Rituximab and trastuzumab Defined Daily Dose (DDD) calculated via IQVIA Real World Data, Oncology Dynamics physician surveys
on average cycles; pre-2009 analysis includes extrapolated treatment days for biosimilars launched between 2005 – 2008; country cohort includes
30 countries within Europe Economic Area; Medicines for Europe estimates September 2017 (700Mn): https://www.medicinesforeurope.com/news/
oncology-the-new-era-for-biosimilar-medicines/
The EU strategy has placed emphasis on improving Fundamentally, biosimilar entry stimulates competition
access to biosimilar medicines (alongside generic, within an established therapy area which has the
and value-added medicines). There will be support for impact of: reducing prices, allowing for more patients
targeted policies to stimulate competition which will to be treated with biologic therapies, earlier treatment
involve more strict application of EU antitrust rules of patients due to reduced costs, savings for additional
to prevent companies that hold drug patents from services, reinvestment in future innovative medicines.
hindering entry or expansion of generic or This report highlights examples of the benefits
biosimilar competitors. biosimilar competition can create, as well as how these
benefits can be unlocked through optimisation.
BIOSIMILARS ARE A SAFE AND EFFECTIVE
ALTERNATIVE TO ORIGINATORS
Biosimilars have provided a safe and effective
alternative to originator biologic therapies for over
15 years and have amassed significant clinical Treatment with biosimilar
experience to support their usage. Treatment with
biosimilar medicines has exceeded 2 billion patient
medicines has exceeded
treatment days since 2005 (see Exhibit 5), and 2 billion patient treatment days
continues to increase exponentially. Regulations
since 2005 and continues to
ensure there are no clinically meaningful differences
between the biosimilar and the reference medicine in
increase exponentially.
terms of safety, quality and efficacy.8 However, hurdles
to usage and biosimilar awareness still remain in
many markets.

trends. These molecules have varied purchasing and
Current trends in patient
use characteristics, and along with the countries
access to biologic therapies selected, serve as a useful basis to take learnings from
biosimilars in Europe.
NATIONAL AND REGIONAL ACCESS DYNAMICS
The sustainability of the biosimilars marketplace
was assessed across a set of five European markets,
with a broad spectrum of systems and approaches.
A set of four biologic medicines, and a structured “Limited access for patients is
sustainability framework made of 9 metrics
a symptom [of a sub-optimal
(see Exhibit 6 and Appendix) was used to determine
examples of sustainable practices, and areas for system] not a cause.”
system optimisation that can be used across
— Key Opinion Leader (Poland)
European healthcare systems. The studied markets
have a mix of national (Austria, France, Poland),
and regional systems in three Italian regions
DRIVERS OF ACCESS
(Lombardy, Sicily, Puglia), and three Spanish regions
The uptake of small molecule generics has been
(Andalusia, Catalonia, Navarra) to offer a range of
strongly payer-driven by allowing automatic
granular insights.
substitution by pharmacists, introducing mechanisms
to reduce price, and in most cases eliminating
The analyses considered caveats such as
prescriber choice. In a biosimilar context, the
administration route (healthcare professional
EMA regulatory process excludes from their remit
intravenous administration versus patient
the topic of interchangeability (a fundamental
subcutaneous self-administration); distribution
element of biosimilar policies) and instead leaves
channel presence (hospital versus retail setting); and
interchangeability decisions to individual countries
chronic (anti-TNFs) versus acute (oncology) dynamics.
as part of national policy. The EMA has not provided
Biosimilars for the four biologic medicines chosen a specific note on the issue on the basis of scientific
were launched in the European market, thus studies, and the consensus has been that patient
allowing for an analysis of relatively recent biosimilar switching should be physician-led. It is important that
competition, as well as investigation into historical a switch decision balances medical and cost reasons.
Exhibit 6: Countries and Molecules Studied
COUNTRY REGIONS COVERED

CATEGORY MOLECULE
Austria National
adalimumab
France National
Anti-TNFs etanercept
Poland National
National and regional infliximab

Italy
(Lombardy, Sicily, Puglia)
National and regional Oncology trastuzumab

Spain
(Andalusia, Catalonia, Navarra)
Within this report, interchangeability, switch, and Therefore, patient access and competition within the
substitution are defined according to the EMA. 9
market are more reliable measures of how effectively
Advancing beyond the generic approach has markets are leveraging the biosimilar opportunity.
implications for long-term sustainability. Although High biosimilar uptake is not necessarily the only way
there are increasing biosimilar penetration rates in to achieve high savings, and savings are not always
Northern Europe, physician and patient choice remain correlated to high or increased access to a biologic by
an important part of the value proposition. While in the population.
all European countries the switch is currently driven by
the treating physician, with markets like Germany and In Poland, for the molecules in scope, biosimilar
Norway considering automatic pharmacy substitution that penetration is greater than 70% (for adalimumab,
removes the physician choice, this may pose a significant etanercept, and infliximab), and access has improved
risk to the long-term sustainability of the system. by 20%–120%. However, the usage remains
dramatically lower than the European average per
UPTAKE IS NOT THE SAME AS ACCESS
capita. Austria by contrast has relatively low biosimilar
In a sustainable market, the originator can compete
share due to historic legislation that restricted
alongside biosimilars. This dynamic means that
biosimilar uptake. Despite strong usage of biologic
previous assessments for ‘success’ in a market with
medicines, Austrian growth in access is below the
biosimilar competition can be misleading. With
European average for the molecules studied.
originator manufacturers actively competing on
price upon loss of exclusivity, markets can have the
In the exhibit below, a high biosimilar market share is
appearance of delayed access to biosimilar medicines.
shown to have a limited relationship to patient access
Stakeholders should avoid using volume uptake of to biologics (see Exhibit 7). In instances where access
biosimilars versus originators as the key performance has grown significantly, this is from a low baseline.
indicator (KPI) for successful implementation of These countries had an overall low usage of the
biosimilar policies as it is not a reliable indicator molecule in clinical practice and remain below the
for savings nor access, given the market dynamics. European average.
Exhibit 7: The Limited Correlation Between Biosimilar Uptake and Increased Access to Therapy Ordered by
Date of Entry
Anti-TNFS Oncology
adalimumab etanercept infliximab trastuzumab

100 100
80 80
*Growth in access
Growth in access
60 60
40 40
20 20
0 0
-20 -20
-40 -40
0 20 40 60 80 100 0 20 40 60 80 100 0 20 40 60 80 100 0 20 40 60 80 100
Current biosimilar market share (%, 2020) Current biosimilar
market share (%, 2020)
Bubble size represents treatment days per capita
Source: IQVIA MIDAS ® Q4 2020 analysis

Exhibit Notes: * = Increase in treatment days per capita versus the year before biosimilar entry

Pillars and pitfalls for highlight examples of sustainable practices within
their system. The report focuses on the positives,
sustainability in European highlighting examples of best practice and policy
biosimilar markets hurdles using the framework below.
THERE ARE SUSTAINABLE PRACTICES IN ACTION The current situation with the European markets is
Reviewing the healthcare systems across the compared to an ideal market scenario (see Exhibit 9).10
individual elements of the ‘Biosimilar Sustainability This provides best practice approaches for each
Assessment Framework’ shows areas that have a positive element of the ‘Biosimilar Sustainability Assessment
improvement or pose a potential risk to sustainability. Framework’. Each country has a unique policy footprint
From working closely with experts in each of the and has started from different positions. The journey
chosen countries and regions, we were able to to a sustainable market is therefore different for
Exhibit 8: Biosimilar Sustainability Framework
REGULATORY AND PMA COMPETITIVE PRESSURE INCENTIVES
Regulatory and PMA pathway Level of competition Patient benefits
Treatment guidelines Pricing rules and dynamics Provider and prescriber benefits
Switching and substitution policies Procurement Awareness and education
Source: IQVIA Institute for Human Data Science, Advancing Biosimilar Sustainability in Europe – A Multi-Stakeholder Assessment, 2018; IQVIA Institute
for Human Data Science, Country Scorecards for Biosimilar Sustainability, 2020.
Exhibit 9: Criteria for the Sustainable Market

ACCESS TO BIOLOGICS
1 Signficant increase to biologics since biosimilar entry*
1
REGULATORY AND PMA
2
2 Regulatory and PMA pathway: ensuring timely access to biosimilars
following EMA approval
3 Treatment guidelines: recommending biosimilar use
4 Switching and substitution policies: at physicians’ discretion while
9 3
preventing automatic pharmacy substitution
COMPETITIVE PRESSURE
5 Level of competition: high level of competition with multiple players 8 4
6 Pricing rules and dynamics: prices driven by competition only
7 Procurement: systems which support competition and drive uptake
in the market
INCENTIVES
7 5
8 Patient benefits: effective benefits encouraging biosimilar use 6
9 Provider and prescriber benefits: effective benefits supporting In an ideal biosimilar market, all data points
biosimilar usage lie on the outer-most perimeter
1 Awareness and education strong awareness of biosimilar benefits Market A Ideal market
and sustainable practices across stakeholder groups
Not sustainable Ideal/most sustainable
* Defined as >25% increase in DDD per capita
each country, but using this approach highlights the occurs within 0-2 months. Where biosimilar access
common opportunities to optimise the system and has not occurred, this is due to very low usage of the
unlock the benefits. A deep-dive on these countries originator drug. Often pricing and reimbursement
and regions is provided in the 1-page summary for processes are less restrictive than the intellectual
each country and region (see Appendix). property associated with biologic medicines. Enbrel
(etanercept) lost exclusivity in 2014, however in this
REGULATORY, PRICING, REIMBURSEMENT AND instance biosimilars were not authorised in Europe
MARKET ACCESS limiting biosimilar entry due to further patent
Regulatory and reimbursement pathways are not protections (see Exhibit 10), but when happened,
currently a hurdle a similar pattern was observed across countries.
In the countries studied, research did not highlight
local country approval times as a significant concern Treatment guidelines largely support biosimilars
given the central processes for biosimilar approval and Official medical guidelines must always be based
quick translocation into the country authorisation. on scientific evidence, not economic considerations.
Guidelines generally encourage the use of biosimilars
Viewing the molecules in scope versus the European as long as they are up to date, especially for naïve
launch date, in many instances, access to the biosimilar patients (optional for most geographies in scope).
In Italy for example, the second position paper
published by AIFA (the ‘Secondo Position paper AIFA
sui Farmaci Biosimilari’, published in 2018) is a positive
“In the beginning all stakeholders step towards sustainability. The publication marked
5 years since the original paper published in 2013,
were sceptical about biosimilars, and provides general guidelines encouraging use of
however acceptance of biosimilars biosimilars, including switching experienced patients,
with decision being made by the physician only.
is much better now and it will
However, there is no detailed guidance on how, when
increase further.” or under what circumstances to consider the switch in
— Key Opinion Leader (Austria) the experienced patient.
Exhibit 10: Time from EMA Approval to First Sales of Biosimilars (Ordered by Earliest Date of Entry)
Months from biosimilar entry
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
inflximab
etanercept
adalimumab
trastuzumab
Austria France Poland Italy Spain

Source: IQVIA MIDAS ® Q4 2020
Exhibit Notes: Biosimilar entry takes into account instances where loss of exclusivity occurs before biosimilars have been authorised for use in Europe,
or where sales are present before time to authorisation. The European baseline for biosimilar entry is usually based on the limiting factor of these two
components.

therefore not a hurdle to sustainability, however the
concept of pharmacy-level substitution remains a
“We have made great progress concern for sustainability. Treatment initiation for
naïve patients with a biosimilar is widely extended
towards greater sustainability
in day-to-day clinical practice for the indication in
since AIFA’s [second] position which the biosimilar conducted the clinical trial for
paper, but we have to iron out registration. However, prescribers are reluctance to
the remaining issues.”

switch experienced patients to a biosimilar despite the
establishment of switching policies and prescription in
extrapolated indications is limited.
— Payer (Italy)
Limited switches are driven by lack of specific clinical

Treatment guidelines do often differ significantly
data, education and incentives to both patients and
between regions. Regions can introduce various
physicians, rather than policies. The implementation
incentives to increase biosimilar utilisation but again,
of forced-switching policies (via automatic pharmacy
no detailed guidelines on patient switch is provided.
substitution) in other countries (such as Norway or
Some regions (e.g. Emilia Romagna, Veneto, Tuscany)
expected in Germany in 2022), rather than addressing
issue strong recommendations, which seems to
data and education gaps, is a concern given the
positively impact biosimilar uptake, but this is driven
precedent that it creates while a formal approach is
in most cases by new treatment initiations and
yet to be considered by the EMA.
not switches.
COMPETITIVE PRESSURE
Poland is an outlier in this regard. Treatment guidelines
Level of competition becomes the most
are considered as the main reason for restricted access
important metric
to biologic therapies. Biologics are considered an
For the countries in scope, low levels of competition
advanced therapy, often positioned last in treatment
can often be a consequence of other issues rather than
guidelines. These ‘drug programs’ limit overall patient
a cause. While historic perspectives on biosimilars have
access to biologics, and cap the treatment duration.
focussed on key performance indicators dedicated
This helps to explain the lower than EU average TD/
to uptake curves and market share, increasingly, our
capita for all molecules. Authorities and payers are
approach has been updated focussing on ‘level of
cautious of softening the criteria to access a biologic
competition’.
treatment due to fears of the healthcare budget being
increased by new patients eligible for them. Both Austria and Poland currently implement single-
winner tenders. Where tenders are used in Austria, we
Substitution and switching
oftentimes see single-winner tenders. This significantly
Pharmacy substitution without physician input is not
restricts physician choice and may render the market
officially implemented in the countries in scope, and is
unattractive for manufacturers, reducing competition.
Compounding this, the short delivery time (~1 month)
from the time of winning the tender creates a risk of
“Although being very keen on supply shortages.
biosimilars and maintaining Italy has implemented multi-winner tenders which are
a positive step towards a sustainable market. However,
low prices, authorities do not formulary inclusion of only one of the tender’s winner
want to ease access to biologic (usually the lowest priced drug) in individual hospitals
therapies.” significantly limits competitiveness of the market.
A comparative analysis using Sweden, viewed single
and multi-winner tenders and found that multiple-
winner tenders may result in lower average net “I believe it would be hard to
molecule costs per defined daily dose (DDD) for
achieve bigger price reductions
a region overall. Cost savings occur since price
reductions are obtained on all contracted products than what we have achieved
(often including the originator) in multiple-winner already.”
tenders rather than only on one product in single-
tender winner scenarios. Multi-winner tenders also — Payer (Italy)
kept multiple manufacturers actively engaged,

commonly reduced prices of all winning brands, hold marketing authorisations for the individual
respected physician’s choice, and enabled patient molecules, resulting in the potential for a competitive
continuation on current treatment. market however, only a subset of these are actually
active within the Italian market (average of 3 players)
In a sustainable market, originators can continue
due to tender awarding dynamics. Those with other
to play a role alongside biosimilars. However,
unsustainable practices, such as Austria and Poland
originators may have high market share due to several
with decisions based on price only, will not be able
non-sustainable reasons: reluctance of HCPs (lacking
to achieve long-term savings through continued
education, awareness or clear evidence for biosimilar
competition.
safety and quality), key opinion leaders sticking to
originators in some regions (e.g. Navarra), novel route Pricing rules and dynamics are at high risk
of administration introduced, or simply due to high of unsustainability
competition in some regions (e.g. Andalusia) with These are not seen as a hurdle by payers who always
high volumes available. benefit from biosimilar competition to some extent.
Importantly, manufacturers (both originator and
Analysing the data in this study, Austria and Italy are biosimilar) might be creating the impression that price
shown at the higher end of the Herfindahl-Hirschman erosion is a constant as they bid to win tenders based
Index (HHI) for market competitiveness (see Exhibit 11). on lower prices. Manufacturers who simply provide
In Italy, multiple manufacturers (average of 5 players) a lower price are rewarded with the tender. This has
Exhibit 11: Herfindahl-Hirschman Index of Market Concentration (Ordered by Date of Entry)

1.0
0.9
Austria
0.8
Index (level of competition)
Herfindahl-Hirschman
0.7
0.6 France
Austria
0.5 France Spain Poland
Spain Italy Italy Spain
0.4 Austria EU
France Poland EU average average Poland Austria EU average
0.3 Poland
Spain France
Italy
0.2 Italy
EU average
0.1
0.0
infliximab etanercept adalimumab trastuzumab
Molecule
Source: IQVIA MIDAS Q4 2020 analysis using the Herfindahl-Hirschman index (HHI) which measures the concentration of markets using market share
®
and the total number of competitors to create a scoring system that represents the competitiveness of markets.

the potential to create the expectation from a payer factors such as packaging adaptation, readability of
perspective that price is erodible upon initiation of labelling, health traceability, support and stability data.
each tendering period which is not the case. This Including non-financial criteria creates an incentive
race to the bottom approach results in fewer able to for manufacturers to innovate, providing further
compete long-term and risking supply. support to patients and providers. These criteria may
not be unique to biologic tendering but it is part of
Interviews with experts highlighted that authorities
the broader sustainability concept and it represents a
and payers are focused mostly on savings,
first step towards a more sustainable procurement as
with all other factors (patient access, level of
it shifts the focus from price-only tenders — included
supply, sustainability) being less of a priority in
those on biosimilars — and may serve as example for
their decision-making purchasing processes.
other contracting authorities.
Manufacturers could therefore use other approaches
to differentiate biosimilars from the originator such INCENTIVES
as new formulations, device improvements such Patient benefits are rarely patient-centric
as autoinjectors to facilitate self-administration, or Patients may have a reluctance to support prescriber-
provision of value-added services. recommended switches, a response which is based on
the psychology of chronic conditions. The attachment
to treatment from the patient becomes higher as they
interact with the administration device, therefore
“I agree with the definition of having greater resistance to switch to subcutaneous,

self-administered biologics from intravenously
sustainability, although the administered ones. This reluctance is usually coupled
focus for some remains entirely with the short time that physicians have for routine
on savings.”
visits with the patients, in which the switching rationale
cannot be fully discussed and agreed.
— Payer (Austria)
Addressing patient reluctance to switch by
building drug improvements (e.g., new modes of
administration, easy-to-use injection devices) are
Procurement beyond price
routes to offer a patient-centric solution, and reduce
Short-term approaches to tendering (e.g. price as
the patient’s concerns when following a physician-
only decision factor, or single-winner tenders) are
led switch. Patient education is intrinsically linked
unsustainable and suboptimal. Countries with multi-
to physician education, and the time available with
winner tenders will reap the benefits of longevity, and
the patient. Physicians with both the capability
support a more competitive marketplace.
and capacity to explain a complex situation will
Countries in scope (Austria, Poland) have single-winner have greater success. This education is driven
tenders with winner criteria driven by price only. Using by pharmaceutical companies, but requires all
criteria beyond price encourages development of stakeholders to collaborate and be open to the
biosimilars with strong value proposition, maintains partnership approach.
physician prescription choice and sustainable
Healthcare systems that use approaches such as full
competition, or sufficiently large tender volumes to
reimbursement of only the cheapest available biologic
ensure attractiveness for manufacturers.
are considered unsustainable, and should therefore
The University Hospital of Bordeaux in France not be used to advocate for non-clinically driven switch.
published a tender for infliximab comprising a point- Patient-centric approaches from pharma coupled
based system including both therapeutic and technical with payer support are optimal. Success depends on
two main factors: the route of administration, and In oncology, the use of biosimilars may free budget for
chronicity of the disease. In IV-administered drugs, more innovative treatment options. Prescribers usually
where a patient does not have direct visibility to the drive greater uptake in biosimilars due to the high, and
medicine, a switch is easier and faster as the time growing cost of innovative oncology treatments. In
dedicated to the patient is shorter, and there is higher other therapy areas, such as dermatology, this is less
prescriber pressure to drive switching, e.g., hospital- frequent, and innovative medicines tend to be priced at
administered drugs such as bevacizumab, filgrastim, the same level as previous therapies. It is also the case
infliximab. For self-administered medicines, the switch that dermatologists have a longer treatment course,
is more difficult as patients interact with the device, and treatment with a biologic (originator or biosimilar)
and therefore the rationale for switch needs to be is often prescribed with less urgency.
explained, as the device usually changes. Physicians
Regions in both Italy and Spain have been able
and other healthcare professionals need to dedicate
to successfully implement systems that make
additional consultation time to inform patients, and
stakeholders aware of the benefits from biosimilar
support with the switch through training on the new
competition. In Spain, the region of Navarra is
device. Alongside this, the impact of the severity of the
estimated to have saved ~€10 million annually
disease has a direct correlation to patient’s reliance on
in recent years due to the impact of biosimilar
the brand name of a treatment.
competition. This has been reinvested in acquiring
Prescriber benefits high-technology medical equipment, improving
The benefits of biosimilar competition are often not healthcare infrastructures and increasing access to
visible to all stakeholders. Savings are shared at an innovative high-cost drugs. Along other measures,
aggregated level or are commercially sensitive due to the health services introduced an indicator to monitor
the price level submitted to a tender. Prescribers are biosimilar prescriptions at hospitals and give visibility
therefore rarely clear on the benefits that biosimilar to prescribers.
competition has provided to the healthcare system,
Prescription quotas are considered a restrictive
especially to their department.
practice, but the monitoring and effective
Direct financial benefits are likely to face legal issues communication of the savings is an important step
and in fact would be unfavourable for physicians, towards optimising healthcare systems to benefit from
risking their freedom of choice. A more sustainable biosimilar competition.
approach involves reinvesting achieved savings in
Awareness and education are the foundation for all
prescriber’s department in the hospital. This often
policies: All stakeholders should publicly advocate
requires the creation of a system that can track this
the benefits achieved such as communicating how
effectively. This type of gain-sharing approach is
many more patients have been treated, the new
limited by the therapy area.
“HCPs don’t have a choice with single-winner tenders, being forced to

use brands available in the hospital formulary… with prescription being
usually issued by INN, HCPs may not even be aware which brand is being
administered to the patient.”

equipment purchased, or the scale of overall savings
Transitioning to practices that
to be reinvested into other innovative medicines. This
demonstrates the value being provided by biosimilar
create sustainable markets for
competition. This requires regular calculations and biosimilars
tracking across markets.
Optimisation is the next phase for European
healthcare systems
Progress towards a more sustainable model for
“Experience with biosimilars is healthcare has been made and is illustrated by the
examples throughout this report. Many of the best
still lacking, with many involved practice approaches that support sustainability are
parties not being familiar with already present in Europe, though not consistently in
every country. Countries have an opportunity to assess
biosimilars, although it has their current position, reflecting on the successes and
been changing, especially since areas for improvement in anticipation of the increasing
LoE opportunity.
the introduction of the National
Plan of Action.” Procurement and effective benefits remain a
critical hurdle
— Regional Payer (Spain)
The countries studied performed poorly in the
adoption of sustainable purchasing policies.
To support strong biosimilar use and competition in Procurement beyond price, and allowing multiple
Denmark, health authorities promoted discussion winners is necessary to maximise the historic
groups with medical societies, prepared educational opportunity, and for the upcoming biologic LoEs.
materials for both patients and physicians, prepared However, tangible benefits to a prescriber (often
existing patient databases to collect real-world referred to as incentives) remain the least optimised
evidence (RWE) and monitor switches. These actions segment of all markets. Further advocacy and
contributed to increased biosimilar awareness, implementation of effective prescriber benefits and
building confidence and trust in biosimilars among support is required.
prescribers. The approach has been to bring clinicians

Payers and providers should promote alignment
on the journey proactively, rather than pressure
of common objectives across stakeholders and
clinicians upon the arrival of biosimilars.
promote the adoption of sustainable approaches to
Alongside this, it remains the task for all stakeholders support biosimilar uptake, ensuring that physician
to educate, but also to empower physicians. It is prescription choice and patient preferences are
critical that all stakeholders understand the full value respected, alongside a healthy level of competition
of biosimilars and that physicians are comfortable and supply. A benefit to the department, or visibility to
prescribing them in all markets, and in the expanding the savings has been shown to be a motivating factor.
number of therapeutic indications. This can be The risk of not doing so can lead to implementation of
achieved by educating prescribers on the laboratory unsustainable practices such as automatic pharmacy
testing as a robust method for assessing biosimilars, substitution that negate patient and physician
and on a secondary basis providing additional clinical involvement in treatment decision, disrupt market
and real-world data to address prescriber prejudice on forces, and overall bring uncertainty to
interchangeability of biosimilars and originators. all stakeholders.
Education alongside legislation are brought along on the journey rather than a
The need for greater physician and patient education reactionary approach.
continues in Europe. It is often expected that a policy
or legislative hurdle is holding back biosimilars in Each country will face a unique journey
countries, however from the research and on-going Each country has a unique policy footprint with
conversations with multiple stakeholders it remains multiple options to optimise (see Exhibit 12), however
the root cause of many of the issues seen in policy and the ideal market is one which has sustainable policies
prescribing patterns. By providing education to policy in all categories and can maximise the benefits for all
makers, physicians, and patients, alongside visibility stakeholders. Biosimilar sustainability is an important
to the benefits of leveraging biosimilar competition, component of the overall sustainability of a healthcare
healthcare systems will be able to benefit as the system in increasingly challenging times. For specific
examples throughout this report show. recommendations to improve sustainability in the

markets studied, please see the deep-dive summaries
Streamlined processes become ever more critical in the Appendix.
The number of therapy areas eligible for biosimilar
competition is due to increase and at present, the
“The prerogative for all

process does not cause significant delays across
Europe. However, with the volume of molecules
expected to lose exclusivity, the manual processes countries, regardless of current
currently used will create a backlog or sub-optimal
approach to implementing biosimilar competition.
biologic usage, is to optimise
There is a need to prepare easily implementable plans the potential from historic
to reap the full benefits in anticipation of the biologic
bubble. Countries can learn from the Nordic system
loss of exclusivity, while
where preparation for upcoming LoE events should be simultaneously preparing
done in advance, up to 5 years in the future and plans
for the future.”
for difference scale launches. This is a critical success
factor to ensure physicians, payers, and patients — Payer (France)
Exhibit 12: Unique Footprints of the Markets Studied

Access to biologics
Awareness and education Regulatory and PMA pathway
Provider and prescriber benefits Treatment guidelines
Patient benefits Switching and substitution policies
Procurement Level of competition
Pricing rules and dynamics
Austria France Poland Italy Spain
Source: IQVIA PMR analysis and MIDAS ® data Q4 2020

Exhibit Notes: Analysis includes national level perspectives only. Regional breakdown is included within the appendix for 3 regions for both Italy and
Spain where areas within the analysis may differ to the national picture.

Notes on sources
This report is based on the IQVIA services
detailed below.
IQVIA MIDAS™ is a unique platform for assessing Biosimilars Landscape Tracker offers summaries
worldwide healthcare markets. It integrates IQVIA’s of biosimilar regulatory, policy, pricing and market
national audits into a globally consistent view of access landscape and biosimilar sales across multiple
the pharmaceutical market, tracking virtually every developed and emerging markets.
product in hundreds of therapeutic classes and
Biosimilar Knowledge Connect centralises news,
provides estimated product volumes, trends and
information and resources pertaining to biosimilars.
market share through retail and non-retail channels.
ARK Patent Intelligence provides insights into the

intellectual property of medicines detailing their
unique patent lifecycles, interdependent exclusivities
across countries, and detailing the specific molecular
patents for medicines across the globe.
Methodologies
BIOSIMILAR SUSTAINABILITY ASSESSMENT IQVIA BIOSIMILAR SUSTAINABILITY PRIMARY
FRAMEWORK MARKET RESEARCH PROGRAMME
Research into this topic included both qualitative A primary market research study was performed from
and quantitative analyses of relevant IQVIA data February to April 2021 and included discussions with
sources, secondary research, as well as consolidation 43 stakeholders from countries in Europe (including
of insights from discussions with IQVIA biosimilar payers, policy makers, thought-leaders from IQVIA and
experts, relevant Biogen affiliates and external policy Biogen employees) in order to validate analytic findings
experts. Secondary research using external and IQVIA on the current biosimilar landscape in each market and
publications was performed to obtain a preliminary to obtain insights on future policy developments likely
view on the current biosimilar landscape in each to have an impact on sustainability in the biosimilars
market, and to inform the relevant qualitative metrics marketplace.
included in the framework. IQVIA MIDAS sales data
and data from other public sources (e.g., EMA) were
used to estimate the remaining quantitative metrics
included in the framework. All price related metrics are
based on list prices, which can be robustly gathered
and referenced across the markets in scope.

References
1. IQVIA Institute analysis (May 2021)
2. EMA EPAR list (last accessed April 2021). Available at: https://www.ema.europa.eu/en/medicines/
download-medicine-data
3. IQVIA Institute for Human Data Science, 2018 and Beyond: Outlook and Turning Points (2018). Available
at: https://www.iqvia.com/institute/reports/2018-and-beyond-outlook-and-turning-points
4. The Impact of Biosimilar Competition in Europe 2020 (2021). Available at: https://www.iqvia.com/library/
white-papers/the-impact-of-biosimilar-competition-in-europe
5. IQVIA Institute for Human Data Science, Advancing Biosimilar Sustainability in Europe (2018). Available
at: https://www.iqvia.com/insights/the-iqvia-institute/reports/advancing-biosimilar-sustainability-in-
europe
6. IQVIA Biosimilar Sustainability Primary Market Research Programme, expert interviews conducted 2021
7. European Commission, European Pharmaceutical Strategy (2020). Available at: https://ec.europa.eu/

health/human-use/strategy_en
8. European Medicines Agency’s guidance on biosimilar medicines. Available at: https://www.ema.europa.

eu/en/human-regulatory/overview/biosimilar-medicines-overview
9. European Medicines Agency, Biosimilars in the EU - Information Guide for Healthcare Professionals
(2017). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/
WC500226648.pdf
10. IQVIA Institute for Human Data Science and Medicines for Europe, Country Scorecards for Biosimilar
Sustainability (2020). Available at: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/country-
scorecards-for-biosimilar-sustainability/iqvia-biosimilar-scorecard-idealised.pdf
Appendix
The Sustainability of Regional Healthcare Systems
Assessment of Austria
The definition of biosimilar sustainability

Biosimilar sustainability improves patient access and physician prescription choice of safe and high quality biologic
medicines, in a framework that considers the needs of all stakeholders (patients, healthcare professionals / providers,
and manufacturers), provides a means to manage existing healthcare budgets while safeguarding a healthy level of
competition and supply.
Biosimilar sustainability assessment framework

CRITERIA FOR IDEAL SUSTAINABLE MARKET
ASSESSMENT OF AUSTRIA
• ACCESS TO BIOLOGICS
Signficant increase to biologics since biosimilar
entry (>25% increase in TD/capita).
Access to
biologics
• REGULATORY AND PMA Awareness Regulatory and
Regulatory and PMA pathway: ensuring timely
access to biosimilars following EMA approval; and education PMA pathway
Official treatment guidelines: recommending
biosimilar use;
Switching and substitution: at physicians’ Provider and
prescriber Treatment
discretion while preventing automatic pharmacy guidelines
substitution. benefits
• COMPETITIVE PRESSURE
Competition: high level of competition with Switching and
multiple players; Patient substitution
Pricing rules and dynamics: benefits policies
prices driven by competition only;
Procurement: systems which support
competition and drive uptake in the market. Level of
Procurement
• INCENTIVES competition
Patient benefits: effective benefits Pricing rules
encouraging biosimilar use; and dynamics
Provider and prescriber benefits: effective
benefits supporting biosimilar usage;
Awareness: strong awareness of biosimilar
benefits and sustainable practices across
stakeholder groups.
Supporting data
GROWTH IN ACCESS VS. USAGE (TD/CAPITA) OF MARKET COMPETITIVENESS
PRE-BIOSIMILAR ENTRY BIOLOGIC MEDICINE (HHI SCORE)
versus versus
Austria Austria Austria
EU average EU average
adalimumab +11% 0.43 +39% (0.31) 0.83 +118% (0.38)
etanercept +16% 0.14 -53% (0.30) 0.56 +37% (0.41)
infliximab +14% 0.24 +71% (0.14) 0.38 +52% (0.25)
trastuzumab -14% 0.04 -20% (0.05) 0.34 +3% (0.33)
Less
Less sustainable
sustainable than
than EU
EU average
average Comparable
Comparable to
to EU
EU average
average More
More sustainable
sustainable than
than EU
EU average
average

Assessment of Austria - continued
PRICING RULES AND DYNAMICS AWARENESS AND EDUCATION
Stringent pricing rules (incl. mandatory price reductions) Limited physician education on interchangeability,
apply to originators and BSM in the retail sector, combined with limited visible benefits to the prescriber to
disincentivizing active switch considerations for physicians drive the best-value biologic.
and patients. • Approach to optimisation: All parties should provide
• Approach to optimisation: Policy makers and payers training and collaborative projects with prescribers
should advocate for sustainable pricing mechanisms (e.g., research collaborations to collect RWE) to improve
which are driven by competition and market dynamics, the usage of biosimilar medicines in Austria.
rather than forced by artificial pricing regulations. • Real-world example: Since 2018, the Dutch biosimilars
• Real-world example: See real-world example under association (IBN), with financial support of the MoH,
Procurement as a potential solution to erode prices in a offers e-learning for hospitals by a group of experts to
more sustainable manner. increase biosimilar awareness and education.
PROCUREMENT
Prevalent use of single-winner tenders, small tender References

volume, short delivery time, and limited criteria beyond
• IQVIA Institute for Human Data Science, Advancing Biosimilar
price.
Sustainability in Europe – A Multi-Stakeholder Assessment,
2018
• Approach to optimisation: Policy makers and payers
• IQVIA Institute for Human Data Science, Country Scorecards
should advocate for procurement rules that require
for Biosimilar Sustainability, 2020
multiple winners and sufficient guaranteed volume,
• NHS Scotland, Effective Prescribing Programme – Optimizing
e.g. through national procurement of high-cost the safe and effective use of biological medicines, 2016
hospital drugs, to secure efficiencies for payers and • CADTH, International Policies on the Appropriate Use of
attractiveness for manufacturers. Biosimilar Drugs, 2018
• Real-world example: Sweden conducted a comparative • BioSim, Gestión Clínica, Incentivos y Biosimilares, 2020
analysis between single- and multi-winner tenders • Moorkens, Vulto et al., Policies for Biosimilar Uptake in
Europe: An Overview, 2017
for infliximab. Results showed that multi-winner
• Moorkens, Vulto et al., Biosimilars in Belgium: a proposal for
tenders kept multiple manufacturers actively engaged,
a more competitive market, 2020
commonly reduced prices of all winning products,
• IBN, IVM project: Biosimilars op Maat (BOM)m 2019
respected physician’s choice and patient continuation on
current treatment.
Appendix
Assessment of France


ASSESSMENT OF FRANCE
Access to
biologics
biosimilar use;
Procurement
stakeholder groups.
Supporting data
versus versus
France France France
adalimumab +22% 0.33 +6% (0.31) 0.62 +63% (0.38)
etanercept -6% 0.12 -60% (0.30) 0.51 +25% (0.41)
infliximab +85% 0.50 +257% (0.14) 0.33 +32% (0.25)
trastuzumab +13% 0.07 +40% (0.05) 0.31 -6% (0.33)
Less sustainable than EU average Comparable to EU average More sustainable than EU average

Assessment of France - continued
REGULATORY AND PMA PATHWAY AWARENESS AND EDUCATION
Slow time to access for biosimilars upon authorisation in Limited physician education on interchangeability,
the hospital setting, driven by tender procedures and combined with limited visible benefits to the prescriber to
tender timing. drive the usage.
• Approach to optimisation: Purchasing organisations • Approach to optimisation: HAS and medical societies
should maintain a horizon scanning plan for upcoming should provide specific guidance for prescribers on
launches before the loss of exclusivity date to initiate biosimilar use, including switching procedures (e.g.
tenders as soon as it is feasible, aiming to balance speed patient characteristics to consider when switching such
versus feasibility to optimise gains. as comorbidities and disease status).
• Real-world example: The Danish system forecasts • Real-world example: The Danish Medicines Council
upcoming expiries 5 years in advance to ensure system published general and specific treatment guidelines for
preparedness via longer term horizon scanning and holds adalimumab biosimilars, including considerations under
multiple off-the-shelf approaches to scale biosimilar entries. which switching is recommended or contraindicated.
PRICING RULES AND DYNAMICS
Although pricing framework provides transparent,

References
predictable guidance for the list prices of biosimilars and • IQVIA Institute for Human Data Science, Advancing Biosimilar
originators, it does not allow for pricing being driven by Sustainability in Europe – A Multi-Stakeholder Assessment,
2018
competition only.
• Approach to optimisation: Policy makers and payers for Biosimilar Sustainability, 2020
should advocate for pricing dynamics led by competition • Danish Medicines Council, Medicinrådets vurdering af
ibrugtagning af biosimilært adalimumab i dermatologien,
to ensure steady price erosion across competitors.
gastroenterologien og reumatologien
• Real-world example: See real-world example under • NHS Scotland, Effective Prescribing Programme – Optimizing
Procurement as a potential solution to erode prices in a the safe and effective use of biological medicines, 2016
more sustainable manner. • CADTH, International Policies on the Appropriate Use of

Biosimilar Drugs, 2018
PROCUREMENT • BioSim, Gestión Clínica, Incentivos y Biosimilares, 2020
• Moorkens, Vulto et al., Policies for Biosimilar Uptake in

Depending on the hospital, there are either single- or
multi-winner tenders.
should advocate for procurement rules that always • IBN, IVM project: Biosimilars op Maat (BOM)m 2019
ensure multiple winners and sufficient guaranteed

volume, to ensure market attractiveness, competition
and respect for physician’s choice.
• Real-world example: Sweden conducted a comparative
analysis between single- and multi-winner tenders for
infliximab. Results showed that multi-winner tenders kept
multiple manufacturers actively engaged, commonly
reduced prices of all winning products, respected physician’s
choice and patient continuation on current treatment.
Appendix
Assessment of Lombardy, Italy


ASSESSMENT OF LOMBARDY, ITALY
Access to
biologics
biosimilar use;
Procurement
stakeholder groups.
Supporting data
versus versus
Lombardy Lombardy Lombardy
adalimumab +29% 0.18 -42% (0.31) 0.43 +13% (0.38)
etanercept +2% 0.08 -73% (0.30) 0.40 -2% (0.41)
infliximab +40% 0.13 -7% (0.14) 0.31 +24% (0.25)
trastuzumab -22% 0.06 -20% (0.05) 0.32 -3% (0.33)

Assessment of Lombardy, Italy - continued
TREATMENT GUIDELINES PROVIDER AND PRESCRIBER BENEFITS
Prescriber reluctance to prescribe biosimilars due to Limited communication in place to highlight the benefits
lack of specific guidance by physician associations on to the healthcare system from biosimilar competition.
patient-switch from originator to biosimilar (e.g. limited • Approach to optimisation: Payers should track and
information on patient characteristics to consider before proactively communicate biosimilar-related budget
switch such as age, condition, co-morbidities, etc.). reinvestment (e.g., access to innovative treatments,
• Approach to optimisation: Medical societies should additional number of patients treated) to all
explicitly endorse biosimilars and extend guidelines to stakeholders.
provide specific guidance for prescribers on the use of • Real-world example: The region of Navarra, Spain
molecules, including switching procedures (e.g. patient estimated savings around €10M annually, which were
characteristics to consider when switching) while also reinvested in acquiring high-technology medical
permitting physician choice. equipment, improve healthcare infrastructures and
• Real-world example: The British Society of increase access to innovative high-cost drugs. Along
Gastroenterology released a guideline on the use of other measures, the health services introduced
infliximab biosimilars for the treatment of inflammatory an indicator within their “Plan de uso racional del
bowel disease, providing clear recommendations on medicamento” to monitor biosimilar prescriptions at
patient switching to guide prescribers and help overcome hospitals and, therefore, support biosimilar uptake.
their reluctance to use biosimilars while supporting
physician choice.
References
PROCUREMENT
Despite multi-winner tendering framework at the national Sustainability in Europe – A Multi-Stakeholder Assessment,
level, non-sustainable price-driven implementation as 2018
oftentimes only one (usually the cheapest) product is • IQVIA Institute for Human Data Science, Country Scorecards
included in the hospital formulary, limiting physician choice.
• Approach to optimisation: As the first step towards a the safe and effective use of biological medicines, 2016
more sustainable market, policy makers and regional • CADTH, International Policies on the Appropriate Use of
payers should ensure implementation of the national
framework is carried through at the regional level and • Moorkens, Vulto et al., Policies for Biosimilar Uptake in
require the inclusion of all tender winners in the hospital
• Servicio Navarro de Salud, Plan de uso racional del
formularies to support physician prescription choice. medicamento 2017-2019, 2017
Considerations beyond price such as guarantee of supply
should generally be included.
analysis between single- and multi-winner tenders
respected physician’s choice and enabled patient
continuation on current treatment.
Appendix
Assessment of Sicily, Italy

medicines, in a framework that considers the needs of all stakeholders (“patients, healthcare professionals / providers,

ASSESSMENT OF SICILY, ITALY
Access to
biologics
biosimilar use;
Procurement
stakeholder groups.
Supporting data
versus versus
Sicily Sicily Sicily
adalimumab +18% 0.21 -32% (0.31) 0.43 +13% (0.38)
etanercept +17% 0.11 -63% (0.30) 0.38 -7% (0.41)
infliximab +29% 0.13 -7% (0.14) 0.38 +52% (0.25)
trastuzumab -1% 0.04 -20% (0.05) 0.50 +52% (0.33)

Assessment of Sicily, Italy - continued
Biosimilar prescription is enforced, with instances of Limited visibility to the benefits of biosimilar competition
prescribers required to fill in justification as under certain despite significant progress in biosimilar uptake and access
circumstances the drug will not be reimbursed; in extreme upon the introduction of biosimilars.
cases the authorisation of the prescribing centre may • Approach to optimisation: Regional institutions
be revoked. should track and proactively communicate the savings
• Approach to optimisation: Medical societies should and benefits from biosimilar competition. They should
explicitly endorse biosimilars, beyond recognizing highlight the healthcare savings, the increased access
interchangeability, and extend guidelines to provide specific to innovative treatments, and the increased number of
guidance for prescribers on the use of molecules, including patients treated since leveraging biosimilar competition.
switching procedures (e.g. patient characteristics to consider • Real-world example: Navarra region (Spain) estimated
when switching) while also permitting physician choice. ~€10M annual savings due to biosimilars, that were
• Real-world example: The British Society of reinvested in acquiring high-technology medical
Gastroenterology released a guideline on the use of equipment, improve healthcare infrastructures and
infliximab biosimilars for the treatment of inflammatory increase access to innovative high-cost drugs. Along
bowel disease, providing clear recommendations on other measures, the health services introduced an
patient switching to guide prescribers and help overcome indicator to monitor biosimilar prescriptions at hospitals
their reluctance to use biosimilars while supporting and, therefore, support biosimilar uptake.
physician choice.
PROCUREMENT
Despite multi-winner tendering framework at the

References
national level, non-sustainable price-driven implementation • IQVIA Institute for Human Data Science, Advancing Biosimilar
as oftentimes only one (usually the cheapest) product is
2018
• Approach to optimisation: As the first step towards a for Biosimilar Sustainability, 2020
more sustainable market, policy makers and regional • Danish Medicines Council, Medicinrådets vurdering af
ibrugtagning af biosimilært adalimumab i dermatologien,
payers should ensure implementation of the national gastroenterologien og reumatologien
framework is carried through at the regional level and
require the inclusion of all tender winners in the hospital the safe and effective use of biological medicines, 2016
formularies to support physician prescription choice. • CADTH, International Policies on the Appropriate Use of
Considerations beyond price such as guarantee of supply Biosimilar Drugs, 2018
should generally be included. • Moorkens, Vulto et al., Policies for Biosimilar Uptake in
analysis between single and multi-winner tenders for medicamento 2017-2019, 2017
infliximab. Results showed that multi-winner tenders
kept multiple manufacturers actively engaged,
Appendix
Assessment of Puglia, Italy


ASSESSMENT OF PUGLIA, ITALY
Access to
biologics
biosimilar use;
Procurement
stakeholder groups.
Supporting data
versus versus
Puglia Puglia Puglia
adalimumab +4% 0.19 -39% (0.31) 0.48 +26% (0.38)
etanercept -22% 0.09 -70% (0.30) 0.50 +22% (0.41)
infliximab -5% 0.15 +7% (0.14) 0.34 +36% (0.25)
trastuzumab -16% 0.07 +40% (0.05) 0.32 -3% (0.33)

Assessment of Puglia, Italy - continued
Prescriber reluctance to prescribe biosimilars due to Limited patient education on biosimilars place an
non-specific guidance by physician associations on additional burden on prescribers to explain process and
patient-switch from originator to biosimilar (e.g. limited rationale for switching.
information on patient characteristics to consider before • Approach to optimisation: All stakeholders
switch such as age, condition, co-morbidities, etc.). should partner to provide information to patients
• Approach to optimisation: Medical societies should and prescribers on biosimilar safety, efficacy,
explicitly endorse biosimilars and extend guidelines to interchangeability and switching, ideally supported by
provide specific guidance for prescribers on the use of clinical data, raising awareness and creating advocacy
molecules, including switching procedures (e.g. patient for biosimilars.
characteristics to consider when switching) while also • Real-world example: The patient association
permitting physician choice. Arthritis Ireland launched an awareness campaign
• Real-world example: The British Society of in collaboration with a manufacturer. This campaign
Gastroenterology released a guideline on the use of combined the expert perspective of a rheumatologist
infliximab biosimilars for the treatment of inflammatory and a patient receiving treatment with the drug.
bowel disease, providing clear recommendations on
patient switching to guide prescribers and help overcome
their reluctance to use biosimilars while supporting References
physician choice.
• IQVIA Institute for Human Data Science, Advancing
Biosimilar Sustainability in Europe – A Multi-Stakeholder
PROCUREMENT Assessment, 2018
Despite multi-winner tendering framework at the national • IQVIA Institute for Human Data Science, Country Scorecards
level, non-sustainable price-driven implementation as
oftentimes only one (usually the cheapest) product is
the safe and effective use of biological medicines, 2016
• CADTH, International Policies on the Appropriate Use of
• Approach to optimisation: As the first step towards a Biosimilar Drugs, 2018
more sustainable market, policy makers and regional • Moorkens, Vulto et al., Policies for Biosimilar Uptake in
payers should ensure implementation of the national
framework is carried through at the regional level and medicamento 2017-2019, 2017
require the inclusion of all tender winners in the hospital
formularies to support physician prescription choice.
Considerations beyond price such as guarantee of supply
should generally be included.
analysis between single- and multi-winner tenders
Appendix
Assessment of Poland


ASSESSMENT OF POLAND
Access to
biologics
biosimilar use;
Procurement
stakeholder groups.
Supporting data
versus versus
Poland Poland Poland
adalimumab +27% 0.04 -87% (0.31) 0.37 -3% (0.38)
etanercept +28% 0.02 -93% (0.30) 0.36 -12% (0.41)
infliximab +129% 0.03 -79% (0.14) 0.31 +24% (0.25)
trastuzumab -7% 0.03 -40% (0.05) 0.50 +52% (0.33)

Assessment of Poland - continued
TREATMENT GUIDELINES AWARENESS AND EDUCATION
Patient access to biologics is limited by restrictive treatment Very low healthcare budget allocation to biologic
guidelines (“drug programmes”, e.g., for anti-TNFs). treatments, and hence the need to strictly control overall
• Approach to optimisation: All stakeholders should work expenditure (e.g. through the implementation of drug
together to develop new guidelines and pricing policies programs), limits awareness among all stakeholders of
that limit expenditure but increase access to biologic the full value biosimilars offer to the sustainability of the
medicines. healthcare system.
• Real-world example: UK’s NHS collected RWE on • Approach to optimisation: Policy makers with clinician
selected areas and molecules to analyse the impact support should drive the advancement of therapy
of switching patients from the originator to a with biologic medicines, leveraging the benefits of
biosimilar. Rheumatology patients on etanercept and biosimilar competition sustainability to minimise
gastroenterology patients on infliximab received a the impact on drug expenditure. In addition, create
biosimilar. This programme demonstrated the possibility greater understanding around the efficacy and safety
of balancing patient care and financial efficiencies, of biologics, as well as their ability to control patient
without having an impact on patients. symptoms and improve overall health status.
• Real-world example: Launch of filgrastim biosimilar led
PROCUREMENT to a decrease in treatment cost that enabled Sweden’s
Exclusive use of single-winner tenders, with small Southern Healthcare Region to relax prescribing
volumes and decision criteria driven exclusively by restrictions (instead of requiring agreement of three
price, significantly limiting physician choice and market prescribers to initiate treatment, prescription of a single
attractiveness. prescriber was sufficient) and resulted in a five-fold
increase in G-CSF uptake.
should advocate for procurement rules that ensure
multiple winners and sufficient guaranteed volume.
References
analysis between single- and multi-winner tenders • IQVIA Institute for Human Data Science, Advancing Biosimilar
for infliximab. Results showed that multi-winner 2018
tenders kept multiple manufacturers actively engaged, • IQVIA Institute for Human Data Science, Country Scorecards
commonly reduced prices of all winning products, for Biosimilar Sustainability, 2020
respected physician’s choice and patient continuation on • NHS Scotland, Effective Prescribing Programme – Optimizing
current treatment.
• BioSim, Gestión Clínica, Incentivos y Biosimilares, 2020


Appendix
Assessment of Andalusia, Spain


ASSESSMENT OF ANDALUSIA, SPAIN
Access to
biologics
biosimilar use;
Procurement
stakeholder groups.
Supporting data (*Limited regional data availability)

Andalusia Andalusia EU average Andalusia EU average
adalimumab — — 0.31 — 0.38

etanercept — — 0.30 — 0.41
infliximab — — 0.14 — 0.25
trastuzumab — — 0.05 — 0.33
* Collecting regional data is complex within Spain; few stakeholders have visibility to the key metrics for biosimilar usage and
uptake. Data published is rarely up-to-date and often does not contain the granularity required to draw conclusions.

Assessment of Andalusia, Spain - continued
PROCUREMENT AWARENESS AND EDUCATION
Requirement for a sustainable multi-winner tendering Awareness and prescriber education still remains the
system considering criteria beyond price that works for all key hurdle to sustainability according to interviews with
stakeholders. local experts.
• Approach to optimisation: Procurement for biosimilar • Approach to optimisation: All stakeholders should
medicines has faced legal challenges in Andalusia, and partner to provide further education to prescribers and
should continue to be created using the most sustainable patients on biosimilar safety, efficacy, interchangeability
approach: leveraging multiple winners, providing winner- and switching, ideally supported by clinical data, raising
criteria beyond price, providing an attractive tender awareness and creating advocacy for biosimilars.
volume and preserving physician prescription choice. • Real-world example: Denmark’s health authorities set
• Real-world example: Sweden conducted a comparative up discussion groups with medical societies, prepared
analysis between single- and multi-winner tenders educational materials for patients and prescribers,
for infliximab. Results showed that multi-winner prepared existing patient databases to collect RWE and
tenders kept multiple manufacturers actively engaged, monitor switches. These actions contributed to increase
commonly reduced prices of all winning products, awareness and build confidence among prescribers.
respected physician’s choice and patient continuation on
current treatment.
References
PROVIDER AND PRESCRIBER BENEFITS
Strong awareness of the benefits of biosimilar competition, Sustainability in Europe – A Multi-Stakeholder Assessment,
2018
but little awareness of where the savings are reinvested
within the system.
• Approach to optimisation: Payers should keep tracking • NHS Scotland, Effective Prescribing Programme – Optimizing
and proactively communicate biosimilar-related budget the safe and effective use of biological medicines, 2016
reinvestment at the regional and hospital level (e.g., • CADTH, International Policies on the Appropriate Use of
access to innovative treatments, increased number of Biosimilar Drugs, 2018
patients treated) across all stakeholders. • Moorkens, Vulto et al., Policies for Biosimilar Uptake in
• Real-world example: UK’s NHS collected RWD on selected
• DANBIO, Dans Reumatologisk Database
areas and molecules to analyse the impact of switching
patients from the originator to a biosimilar. Rheumatology
patients on etanercept and gastroenterology patients
on infliximab received a biosimilar. This programme
demonstrated balancing patient care and financial
efficiencies, without impacting patients.
Appendix
Assessment of Navarra, Spain


ASSESSMENT OF NAVARRA, SPAIN
Access to
biologics
biosimilar use;
Procurement
stakeholder groups.

Navarra Navarra EU average Navarra EU average
adalimumab — — 0.31 — 0.38

etanercept — — 0.30 — 0.41
infliximab — — 0.14 — 0.25

Assessment of Navarra, Spain - continued
PROCUREMENT
Despite efficient tender execution and implementation,

References
single-winner awarding is considered not sustainable as it • IQVIA Institute for Human Data Science, Advancing Biosimilar
limits physician choice.
2018
• Approach to optimisation: Procurement for biosimilar • IQVIA Institute for Human Data Science, Country Scorecards
medicines should continue to be created using the most for Biosimilar Sustainability, 2020
sustainable approach: leveraging multiple winners, • NHS Scotland, Effective Prescribing Programme – Optimizing
providing winner-criteria beyond price, providing an
attractive tender volume and preserving physician
prescription choice.
• Real-world example: The University Hospital of
Bordeaux in France published a tender for infliximab • DANBIO, Dans Reumatologisk Database
comprising a point-based system including both

therapeutic and technical factors such as packaging
adaptation, readability of labelling, health traceability
support and stability data. Including non-financial criteria
creates an incentive for manufacturer to innovate,
providing further support to patients and providers.
AWARENESS AND EDUCATION
Awareness and prescriber education still remains the key

hurdle according to expert interviews.
• Approach to optimisation: All stakeholders should
partner to provide further education to prescribers and
patients on biosimilar safety, efficacy, interchangeability
and switching, ideally supported by clinical data, raising
awareness and creating advocacy for biosimilars.
• Real-world example: Denmark’s health authorities set
up discussion groups with medical societies, prepared
educational materials for patients and prescribers,
prepared existing patient databases to collect RWE and
monitor switches. These actions contributed to increase
awareness and build confidence among prescribers.
Appendix
Assessment of Catalonia, Spain


ASSESSMENT OF CATALONIA, SPAIN
Access to
biologics
biosimilar use;
Procurement
stakeholder groups.

Catalonia Catalonia EU average Catalonia EU average
adalimumab — — 0.31 — 0.38

etanercept — — 0.30 — 0.41
infliximab — — 0.14 — 0.25

Assessment of Catalonia, Spain - continued
PROCUREMENT AWARENESS AND EDUCATION
Although many multi-winner tenders are in place in Catalonia has a sustainable approach in many areas, but
Catalonia, still use of single-winner tenders for some awareness and prescriber education still remains the key
molecules, restricting physician choice and resulting in hurdle according to expert interviews.
reduced levels of competition. • Approach to optimisation: All stakeholders should
• Approach to optimisation: Payers should introduce a partner to provide further education to prescribers and
pure multi-winner tendering system for the region patients on biosimilar safety, efficacy, interchangeability
which is centralised and provides sufficient volume to and switching, ideally supported by clinical data, raising
secure attractiveness for manufacturers and efficiencies awareness, and creating advocacy for biosimilars.
for payers. • Real-world example: Denmark’s health authorities set
• Real-world example: Sweden conducted a comparative up discussion groups with medical societies, prepared
analysis between single- and multi-winner tenders educational materials for patients and prescribers,
for infliximab. Results showed that multi-winner prepared existing patient databases to collect RWE and
tenders kept multiple manufacturers actively engaged, monitor switches. These actions contributed to increase
commonly reduced prices of all winning products, awareness and build confidence among prescribers.
respected physician’s choice, and patient continuation on
current treatment.
PROVIDER AND PRESCRIBER BENEFITS
Prescribers are obliged to provide information to registry

References
in order to have their prescription reimbursed; data is • IQVIA Institute for Human Data Science, Advancing Biosimilar
collected but not further analysed or published, limiting
2018
full visibility to the benefits of biosimilar competition.
• Approach to optimisation: All stakeholders should for Biosimilar Sustainability, 2020
engage in clinical data collection activities (e.g., analysing • NHS Scotland, Effective Prescribing Programme – Optimizing
RWE collected via biologics registry of Catalonia’s the safe and effective use of biological medicines, 2016
Regional Health Department for selected diseases), • CADTH, International Policies on the Appropriate Use of
across all approved indications to ease scepticism on
data extrapolation, interchangeability and switching. Europe: An Overview, 2017
• Real-world example: UK’s NHS collected RWD on • DANBIO, Dans Reumatologisk Database
selected areas and molecules to analyse the impact
of switching patients from the originator to a
biosimilar. Rheumatology patients on etanercept and
gastroenterology patients on infliximab received a
biosimilar. This programme demonstrated balancing
patient care and financial efficiencies, without impacting
patients.
About the authors
MURRAY AITKEN MAX NEWTON
Executive Director, IQVIA Institute Senior Consultant, Global Supplier
for Human Data Science & Association Relations,
IQVIA
Murray Aitken is Executive Director, IQVIA Institute Max Newton is a Senior Consultant with over 6-years
for Human Data Science, which provides policy setters of experience in pharmaceutical consulting, leading
and decisionmakers in the global health sector with diverse projects across policy, government affairs,
objective insights into healthcare dynamics. He led and commercial strategy. Max holds a BSc in Medical
the IMS Institute for Healthcare Informatics, now Microbiology & Virology for Warwick University, and an
the IQVIA Institute, since its inception in January MSc in Drug Discovery & Pharmaceutical Management
2011. Murray previously was Senior Vice President, from University College London.
Healthcare Insight, leading IMS Health’s thought
leadership initiatives worldwide. Before that, he served
as Senior Vice President, Corporate Strategy, from ISABEL RODRÍGUEZ
2004 to 2007. Murray joined IMS Health in 2001 with Principal, Consulting Services,
responsibility for developing the company’s consulting Pricing & Market Access,
and services businesses. Prior to IMS Health, Murray IQVIA
had a 14-year career with McKinsey & Company,
where he was a leader in the Pharmaceutical and
Medical Products practice from 1997 to 2001. Murray Isabel Rodriguez is a Principal within IQVIA Global
writes and speaks regularly on the challenges facing Consulting Services. She has over 15-years of
the healthcare industry. He is editor of Health IQ, a experience in pharmaceutical consulting and has led
publication focused on the value of information in highly diverse projects on pricing and market access,
advancing evidence-based healthcare, and also serves forecasting, acquisitions and geographic expansion,
on the editorial advisory board of Pharmaceutical launch planning and product positioning, among
Executive. Murray holds a Master of Commerce degree others. Isabel holds a BSc in Biology from Universidad
from the University of Auckland in New Zealand, Autónoma de Madrid, in Spain.
and received an M.B.A. degree with distinction from
Harvard University.
MANUEL VÁZQUEZ
Associate Principal, Consulting
DOROTHEE MUGELE
Services, Pricing & Market Access,
Associate Consultant,
IQVIA
Consulting Services,
IQVIA
Manuel Vázquez is an Associate Principal within IQVIA
Global Consulting Services. He has over 11-years of
Dorothee Mugele is an Associate Consultant within consulting experience with a focus on global value
IQVIA Global Consulting Services. She has over 2-years and market access projects and health economics
of consulting experience across healthcare strategy, and outcomes research (HEOR) strategy to support
value and market access projects. Dorothee holds the PMA decision making process. Prior to IQVIA, he
a PhD in Stem Cell Biology from University College worked for six years as a retail pharmacist manager
London and an MSc in Clinical Trials from the London in the United Kingdom. Manuel holds a PharmD from
School of Hygiene & Tropical Medicine. Universidad de Salamanca in Spain and an MBA from
Manchester Business School in the U.K.

About the Institute
The IQVIA Institute for Human Data Science • Researching the role of technology in health system
contributes to the advancement of human health products, processes and delivery systems and the
globally through timely research, insightful analysis business and policy systems that drive innovation.
and scientific expertise applied to granular non-
Guiding Principles
identified patient-level data.
The Institute operates from a set of Guiding Principles:
Fulfilling an essential need within healthcare, the
• Healthcare solutions of the future require fact based
Institute delivers objective, relevant insights and
scientific evidence, expert analysis of information,
research that accelerate understanding and innovation
technology, ingenuity and a focus on individuals.
critical to sound decision making and improved
human outcomes. With access to IQVIA’s institutional • Rigorous analysis must be applied to vast amounts
knowledge, advanced analytics, technology and of timely, high quality and relevant data to provide
unparalleled data the Institute works in tandem value and move healthcare forward.
with a broad set of healthcare stakeholders to drive
• Collaboration across all stakeholders in the
a research agenda focused on Human Data Science
public and private sectors is critical to advancing
including government agencies, academic institutions,
healthcare solutions.
the life sciences industry and payers.
• Insights gained from information and analysis

Research Agenda
should be made widely available to healthcare
The research agenda for the Institute centers on
stakeholders.
5 areas considered vital to contributing to the
advancement of human health globally: • Protecting individual privacy is essential, so research
will be based on the use of non-identified patient
• Improving decision-making across health systems
information and provider information will be
through the effective use of advanced analytics and
aggregated.
methodologies applied to timely, relevant data.
• Information will be used responsibly to advance
• Addressing opportunities to improve clinical
research, inform discourse, achieve better healthcare
development productivity focused on innovative
and improve the health of all people.
treatments that advance healthcare globally.
• Optimizing the performance of health systems by

focusing on patient centricity, precision medicine
and better understanding disease causes, treatment
consequences and measures to improve quality and
cost of healthcare delivered to patients.
• Understanding the future role for

biopharmaceuticals in human health, market
dynamics, and implications for manufacturers, public
and private payers, providers, patients, pharmacists
and distributors.
The IQVIA Institute for Human Data Science is committed to using human data science to provide timely, fact-based perspectives
on the dynamics of health systems and human health around the world. The cover artwork is a visual representation of this
mission. Using algorithms and data from the report itself, the final image presents a new perspective on the complexity, beauty and
mathematics of human data science and the insights within the pages.
The algorithmic art on this report cover is based on usage metrics for biosimilar products in 2020 across the five European countries
covered in the report. This includes sales and volume measures to represent current biosimilar uptake.
CONTACT US
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OF HE ALTHC ARE S YS TEMS

Different stakeholders — from policy makers through to patients — and their

The importance of ‘sustainability’ in markets for biosimilars 3

Current trends in patient access to biologic therapies 7

Pillars and pitfalls for sustainability in European biosimilar markets 9

Transitioning to practices that create sustainable markets for biosimilars 12

Appendix - The sustainability of regional healthcare systems 20

Assessment of Lombardy, Italy 24

Assessment of Puglia, Italy 26

Assessment of Sicily, Italy 28

Assessment of Andalusia, Spain 32

Assessment of Navarra, Spain 34

Assessment of Catalonia, Spain 36

About the authors 38

About the Institute 39

medicines. regions (Andalusia, Catalonia, Navarra) to offer a range

Although many of the best practice approaches that

2 | Spotlight on Biosimilars: Optimising the Sustainability of Healthcare Systems

Exhibit 1: Increasing Importance of the Biologic Medicines Market

Biologic medicines Other medicines

Biosimilar Biosimilar accessible market (ex. biosimilars)

Exhibit 3: Forecast Potential for Biosimilar Competition in Europe

40 Establishment and testing Optimisation and preparation Implementation at scale 70

4 | Spotlight on Biosimilars: Optimising the Sustainability of Healthcare Systems

of biosimilars. They can balance pharmaceutical

Exhibit 4: Definition of ‘Biosimilar Sustainability’

Biosimilar sustainability improves patient

Source: IQVIA MIDAS ® Q4 2020 data

6 | Spotlight on Biosimilars: Optimising the Sustainability of Healthcare Systems

Exhibit 6: Countries and Molecules Studied

COUNTRY REGIONS COVERED

National and regional infliximab

National and regional Oncology trastuzumab

adalimumab etanercept infliximab trastuzumab

Bubble size represents treatment days per capita

Source: IQVIA MIDAS ® Q4 2020 analysis

8 | Spotlight on Biosimilars: Optimising the Sustainability of Healthcare Systems

Exhibit 8: Biosimilar Sustainability Framework

REGULATORY AND PMA COMPETITIVE PRESSURE INCENTIVES

Regulatory and PMA pathway Level of competition Patient benefits

Switching and substitution policies Procurement Awareness and education

Exhibit 9: Criteria for the Sustainable Market

* Defined as >25% increase in DDD per capita

— Key Opinion Leader (Austria) the experienced patient.

Austria France Poland Italy Spain

10 | Spotlight on Biosimilars: Optimising the Sustainability of Healthcare Systems

the remaining issues.”

Limited switches are driven by lack of specific clinical

“Although being very keen on supply shortages.

therapies.” significantly limits competitiveness of the market.

— Key Opinion Leader (Poland)

kept multiple manufacturers actively engaged,

Exhibit 11: Herfindahl-Hirschman Index of Market Concentration (Ordered by Date of Entry)

12 | Spotlight on Biosimilars: Optimising the Sustainability of Healthcare Systems

“I agree with the definition of having greater resistance to switch to subcutaneous,

“HCPs don’t have a choice with single-winner tenders, being forced to

14 | Spotlight on Biosimilars: Optimising the Sustainability of Healthcare Systems

contributed to increased biosimilar awareness, implementation of effective prescriber benefits and

building confidence and trust in biosimilars among support is required.

prescribers. The approach has been to bring clinicians

examples throughout this report show. recommendations to improve sustainability in the

“The prerogative for all

more sustainable manner. • CADTH, International Policies on the Appropriate Use of

PROCUREMENT • BioSim, Gestión Clínica, Incentivos y Biosimilares, 2020

• Moorkens, Vulto et al., Policies for Biosimilar Uptake in

TREATMENT GUIDELINES PROVIDER AND PRESCRIBER BENEFITS

• BioSim, Gestión Clínica, Incentivos y Biosimilares, 2020

• Moorkens, Vulto et al., Policies for Biosimilar Uptake in

• Moorkens, Vulto et al., Biosimilars in Belgium: a proposal for

PROCUREMENT AWARENESS AND EDUCATION