Iqvia Institute Biosimilars in The United States 2023 Usl Orb3393

Biosimilars in the
United States
2023–2027
COMPET I T ION, SAV INGS, AND SUS TA INABILI T Y
JANUARY
2023
Introduction
The first biosimilar approved under the abbreviated pathway established by the
Biologics Price Competition and Innovation Act launched in the U.S. in 2015, while
some non-original biologics have been approved through other pathways both
before and since. Despite slower initial uptake, biosimilar launches in the last
three years have generally been more successful than earlier, raising important
questions for upcoming biosimilars, where savings and patient access could
increase substantially.
In this report, the current state of the biologics market This study was produced independently by the IQVIA
in the United States and share of the market facing Institute for Human Data Science, drawing on IQVIA
biosimilar competition are assessed. Factors impacting proprietary data. Funding for this research and report
biosimilar uptake, including reimbursement and provider has been provided by the Biosimilars Council, a division
type, and the impact of biosimilars on molecule volume of the Association for Accessible Medicines. The
and price are evaluated. Historic biosimilar trends are contributions to this report of Allen Campbell, Sarah
utilized to provide potential future biosimilar spending Markiewicz, Urvashi Porwal, Vibhu Tewary, Tanushree
and savings scenarios. Thakur, Marcella Vokey, and others at IQVIA are
gratefully acknowledged.
We intend for this report to provide a foundation
for meaningful discussion about the value and role Find Out More
of biosimilars over the next five years and the key If you wish to receive future reports from the IQVIA
implications stakeholders should consider as budget Institute for Human Data Science or join our mailing list,
pressures continue to drive healthcare decision-making visit iqviainstitute.org.
in the U.S.
MURRAY AITKEN
Executive Director
IQVIA Institute for Human Data Science
©2023 IQVIA and its affiliates. All reproduction rights, quotations, broadcasting, publications reserved. No part of this publication may be reproduced or
transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without
express written consent of IQVIA and the IQVIA Institute.
Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

Table of Contents
Overview 2
Market dynamics and biosimilar development 4
Factors influencing biosimilar uptake 13
Biosimilar impacts on molecule volume and price 20
Future impacts of biosimilars 26
Notes on sources 33
Definitions and methodology 34
References 35
About the authors 36
About the Institute 38

Overview
The first biosimilar, or competitor product to an In those markets with biosimilars, competitiveness is
existing biologic molecule that is no longer patent highly varied, but being first to launch is generally a
protected, launched in the U.S. in 2007, pre-dating the significant advantage. Development of biosimilars is
implementation of the Biologics Price Competition and being driven by smaller companies, while marketing is
Innovation Act (BPCIA). Early biosimilars had limited done mostly by large companies. In recent years, smaller
adoption and lower savings compared to expectations. companies have begun to market more biosimilars,
By contrast, many biosimilars have launched in recent a trend that is expected to continue with upcoming
years that have achieved significant uptake and savings. biosimilar launches.
The success of these biosimilars suggest shifts in the
FACTORS INFLUENCING BIOSIMILAR UPTAKE
acceptance of biosimilars by healthcare stakeholders.
Recent biosimilars have achieved high volume shares,
With significant launches expected in the next five
reaching more than 60% of the molecule’s volume within
years, it is important to understand the state of the
the first three years. The utilization of biosimilars has
market and the factors that influence their use, and
dramatically changed since 2020. For example, most
to also consider how these factors may impact future
providers are now using a biosimilar of bevacizumab more
biosimilars. Ultimately, it is expected that biosimilars will
than the originator, and few still favor the originator.
generate significant savings in the future, enhancing the
sustainability of the U.S. healthcare system.
Biosimilar utilization can be influenced by how it is
distributed and reimbursed. Biosimilars have had
MARKET DYNAMICS AND BIOSIMILAR DEVELOPMENT
stronger uptake in buy-and-bill, where physicians have an
The U.S. biologics market has grown 12.5% annually on
incentive to select one product over another. Biosimilar
average over the last five years on an invoice-price basis,
products were more readily adopted among professional
faster than non-biologics, and
providers in the first year after launch compared to
now comprises 46% of spending. Molecules currently
institutional providers, but use was at similar levels after
facing biosimilar competition total $38Bn of invoice
two years. Providers participating in the Oncology Care
spending, while a further $96Bn is the target of
Model adopted biosimilars at higher levels compared to
biosimilars in development or approved but not yet
non-participants, highlighting how patient care models
launched. Biosimilars launched to date account for
can impact reimbursement and potentially provide
24% of competitive molecule volume, and 11% of
incentives for increasing the adoption of biosimilars.
total biologic spending at invoice levels is facing
biosimilar competition.
Biosimilar penetration at pharmacies, which so far
relates only to insulin glargine and insulin lispro,
Since 2007, 30 biosimilars have launched across
has remained relatively low. The introduction of
12 molecules in the U.S., with 10 more biosimilars
interchangeable biosimilars and authorized generics
approved and set to launch by the end of 2023. There
has influenced the ability of biosimilars to gain market
are biosimilars approved or in clinical development
share. Interchangeability appears to be an advantage
in the U.S. for 20 molecules in addition to the 12 with
for the specific biosimilar product and may increase
biosimilars already launched. These include biosimilars
uptake. Authorized generics — unbranded versions of
for the best-selling biologic molecule, adalimumab, that
the originator — contribute to savings but retain volume
are set to launch in 2023.
for originator companies.
2 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

BIOSIMILAR IMPACTS ON MOLECULE VOLUME FUTURE IMPACTS OF BIOSIMILARS
AND PRICE Future biosimilar sales and savings will depend on a
The introduction of biosimilars frequently leads to variety of market dynamics. To model this, volume
higher utilization of the molecule as lower costs offer uptake scenarios have been developed including high,
increased access to patients. Over time, the utilization medium, and low, tied to both originator competition
of older treatments subject to biosimilar competition and price reductions ranging from 15–45%.
can decrease as more innovative alternative treatments
Expected launches and uptake are likely to increase
become available. Patient access to successive
overall spending on biosimilars significantly to
generations of originator products has narrowed the
$20–$49Bn in 2027 and cumulative sales of $129Bn over
market ultimately accessible to biosimilars, impacting
the next five years, with at least 10 molecules facing
the potential financial returns for biosimilar developers.
biosimilar competition over the period. Savings over the
Introduction of lower cost biosimilars leads to declines next five years as a result of biosimilars are projected to
in overall molecule costs per unit (i.e., includes exceed $180Bn, though uncertainties remain as market
originator and biosimilars) at invoice prices over time, events to date suggest a wide range of market outcomes
typically driving down costs for originators as well. are still possible.
Absolute savings from biosimilars vary, with larger
savings where originators were more costly including
the 2019 biosimilar launches, which have seen ASP
reductions of $2,526–$4,913, potentially a factor in their
Savings as a result of biosimilars
high uptake. Off-invoice discounts and rebates likely
vary by originator and biosimilar products, reducing are projected to exceed $180Bn
the prices experienced by payers, patients, and other over the next five years.
healthcare system participants. Price reductions and
savings may differ when looking at net prices, including
discounts and rebates.
The immunology market has seen significant growth
The market share maintained by originators after facing in both spending and volume in the last five years, and
biosimilar competition is correlated with the relative the entry of new immunology biosimilars in 2023 will
price reduction in the originator product compared increase competition in this rapidly growing market. The
to the biosimilar. Generally, originators which have best-selling biopharmaceutical in the U.S., adalimumab
reduced prices to similar levels as biosimilar competitors (Humira), will face biosimilar competition beginning in
have lost less volume following biosimilar entry, while 2023, and product characteristics and reimbursement
originators maintaining higher prices see significant decisions are likely to impact biosimilar uptake.
volume loss. As a result, the healthcare system tends
With biosimilars seeing increasing acceptance in the U.S.
to see savings through uptake of lower cost biosimilars
and the scale of spending on medicines facing upcoming
and/or price reductions for the reference product.
biosimilar competition growing, the impact on all
stakeholders will be significant.
iqviainstitute.org | 3
Market dynamics and biosimilar development
• The U.S. biologics market has grown 12.5% annually • There are biosimilars approved or in clinical
on average over the last five years on an development in the U.S. for 20 molecules in addition
invoice-price basis, faster than non-biologics, and to the 12 with biosimilars already launched, with
now comprising 46% of spending. biosimilars set to launch for the best-selling biologic
molecule, adalimumab, in 2023.
• Molecules currently facing biosimilar competition total
$38Bn of invoice spending, while a further $96Bn is the • In those markets with biosimilars, competitiveness is
target of biosimilars in development or approved but highly varied but being first to launch is generally a
not yet launched. significant advantage.
• Biosimilars launched to date account for 24% of • Development of biosimilars is being driven by smaller
competitive molecule volume, and 11% of total companies, while marketing is done mostly by large
biologic spending at invoice levels is facing companies. In recent years, smaller companies have
biosimilar competition. begun marketing more biosimilars, a trend that
is expected to continue with upcoming biosimilar
• Since 2007, 30 biosimilars have launched across
launches.
12 molecules in the U.S., with 10 more biosimilars
approved and set to launch by the end of 2023.
The biologics market continues to grow, with 14% of the market facing
biosimilar competition, a number likely to grow by 15% in 2023 as
biosimilars are expected to launch for molecules with high spending.

The U.S. biologics market continues to grow faster than

non-biologics on an invoice-basis, and now comprises 46% of spending
Exhibit 1: Total U.S. invoice spending growth by type and leading therapy areas by 2021 spending, US$Bn
Year-over-year spending growth Leading drug classes

16%
Immunology 90
Biologics
14%
CAGR 2017-2021: Antidiabetics 84
12% 12.5%
Oncology 78
10%
Total US medicines Respiratory agents 31 Total 2021 US medicine
8% CAGR 2017-2021: spending $568Bn
5.6% Antithrombotics 27
6%
HIV antivirals 26
4%
Mental health 18 Small
2% Biologic
Molecule
Multiple sclerosis 17 46%
0% 54%
Small molecule Vaccines 13
-2% CAGR 2017-2021:
1.3% Pain 12
-4%
2017 2018 2019 2020 2021
Biosimilars available as well as in development
Biologics Small molecule Total US medicines Biosimilars in development
Source: IQVIA MIDAS, Dec 2021; IQVIA Institute, Nov 2022.
• In 2021, the United States spent $568Bn on medicines • Respiratory agents have seen substantial growth in
at ex-manufacturer invoice prices, including $260Bn biologics, with 19.7% CAGR since 2017 due to advances
on biologics, which now comprise 46% of total in severe asthma treatments.
medicine spending.
• Several biosimilar launches occurred in the top three
• Even including the effect of biosimilar competition spending areas in recent years, including biosimilar
over the past decade, biologics spending has increased cancer treatments, insulins, and immunology agents.
significantly since 2017, at a compound annual growth
• Additional biosimilars are in development in
rate (CAGR) of 12.5%, outpacing the 1.3% CAGR for small
these classes, as well as in respiratory agents,
molecules and raising the total market CAGR to 5.6%.
antithrombotics, and multiple sclerosis products.
• The three classes with the highest spending —
• Smaller classes of medicines, such as growth
immunology, antidiabetics, and oncology — account
hormones, osteoporosis treatments, and ocular
for 70% of biologics spending, and their biologics
anti-neovascularization products have biosimilars
growth is at 18.4%, 12.3%, and 14.8% CAGRs,
available, with additional biosimilars in development.
respectively, in the past five years.
Notes: Oncology includes therapeutic agents as well as supportive care. Invoice prices in this report are ex-manufacturer level, reflecting the prices between
manufacturers and their customers (wholesalers or direct purchasers), not including off-invoice discounts and rebates.
Molecules with biosimilars total $38Bn of invoice spending, while

biosimilar development is targeting a further $96Bn
Exhibit 2: 2021 biologics market segmented by status of biosimilar competition and biosimilar development
Molecules facing
14% biosimilar competition
$38Bn Molecules with biosimilars
53% in development
$96Bn
Molecules with potential

Biologics market 70% future biosimilars
$260Bn
$181Bn
Molecules without biosimilars

47% in development
Non-recombinant/ $86Bn
16% vaccines
$41Bn
Source: IQVIA MIDAS, Dec 2021; IQVIA Pipeline Intelligence, IQVIA Institute, Nov 2022.
• The current $260Bn biologics market is already facing • The remaining 70% or $181Bn could face biosimilar
biosimilar competition, with biosimilars launched for competition in the future.
12 molecules representing 14% ($38Bn) of biologic
• Just more than half (53% or $96Bn) of this market
spending (i.e., exposed originators and their biosimilar
currently has biosimilars in development, and the
competitors).
remaining 47% (or $86Bn) has no biosimilars currently
• An additional 16% of the market, or $41Bn, are in development, with these molecules varying in
biologics produced without recombinant technologies, protection status (see Exhibit 3).
such as purified or gathered biologics, thereby making
it impossible to produce a biosimilar, though in some
cases non-recombinant biologics are already facing
generic competition as they are naturally occurring
substances or vaccines without patent protection.
Notes: Generics for non-recombinant biologics include glatiramer acetate, enoxaparin sodium, and a range of vaccines and blood plasma products. Numbers
may not sum due to rounding.

Most of the molecules with biosimilars in development continue to

be protected, with only 7% unprotected
Exhibit 3: 2021 biologics market segmented by status of biosimilar development and market exclusivity
Originator protected 21 molecules

93%
$89Bn Avg sales = $4.2Bn
Molecules with biosimilars
in development
$96B
Originator unprotected 6 molecules
7%
$7Bn Avg sales = $1.2Bn
Originator protected 145 molecules

90%
$77Bn Avg sales = $532Mn
Molecules without biosimilars
in development
$86B
Originator unprotected 33 molecules
10%
$9Bn Avg sales = $260Mn
Source: IQVIA MIDAS, Dec 2021; IQVIA Pipeline Intelligence, IQVIA Institute, Nov 2022.
• There are 27 molecules with biosimilars approved • There are 178 molecules without biosimilar
or in any stage of development: 21 where the development, comprising the remaining $86Bn. The
originator remains protected by exclusivity and 145 molecules currently protected generated $77Bn
6 that are unprotected. in spending or $532Mn on average. Many of these
are recently launched and have not yet generated
• The 21 molecules with biosimilars in development that
biosimilar development activity but may in the future.
are still protected generated $89Bn in sales in 2021
and averaged $4.2Bn. This includes the immunology • The remaining 33 without biosimilar development
blockbusters adalimumab (Humira) and ustekinumab are off-patent and generated $9Bn, or an average
(Stelara), which accounted for 40% of this spending of $260Mn, and are not likely to see biosimilar
and will lose exclusivity in 2023. development activity due to lower market potential for
biosimilar companies.
• The six unprotected molecules with biosimilars in
development generated $7Bn in sales in 2021 and an
average of $1.2Bn. Insulin aspart, which lost patent
protection in 2014, accounts for $6Bn of this spending,
and a biosimilar has completed Phase III in the U.S.
The remaining five molecules averaged $216Mn in
sales, with one biosimilar in development each.
Notes: Protected is defined as having an expiry date in the future, while unprotected is defined as having an expiry date in the past. Numbers may not sum
due to rounding.
Biosimilars launched to date account for 24% of competitive

molecule volume
Exhibit 4: Percentage of biologics sales accessible to approved and launched biosimilars and biosimilar
efficiency, Q1 2015–Q3 2022
40%
35%
30%
25%
Share
20%
15%
10%
5%
0%
20 Q2
3
20 Q4
20 Q1
20 Q2
20 Q3
20 Q4
20 Q1
20 Q2
20 Q3
20 Q4
20 Q1
20 Q1
20 Q2
20 Q3
20 Q4
20 Q1
20 Q2
20 Q3
20 Q4
20 Q1
20 Q2
20 Q3
20 Q4
20 Q1
20 Q2
20 Q3
20 Q4
20 Q1
20 Q2
20 Q3
Q
22
22
19
20
20
20
20
21
21
21
21
22
15
15
15
15
16
16
16
16
17
17
17
17
18
18
18
18
19
19
19
20
Percentage of biologics market accessible to biosimilars that are approved but not yet launched (US$)
Percentage of biologics market accessible to launched biosimilars (US$) Biosimilar efficiency (DDDs)
Source: IQVIA MIDAS, Sep 2022; IQVIA Institute, Dec 2022.
• Biologic sales currently accessible to and facing • Biosimilars that are approved but not yet launched
biosimilar competition account for 11% of total represent an additional 13% of total biologic sales,
biologic sales, and biosimilar efficiency — meaning with 10% from adalimumab, which has biosimilars
the percentage that biosimilars comprise of accessible launching this year, and 3% from etanercept, which is
molecule volume — has reached 24%. not expected to face biosimilar competition until 2029.
• The potential savings that biosimilars may bring • The launch of insulin glargine and infliximab
to healthcare stakeholders is often delayed, as is biosimilars in 2016 resulted in a significant rise in the
competition, since the approval of biosimilars does accessible market — from 2% to 12% within the first
not result in their immediate launch. Delays in quarter — and reduction in biosimilar efficiency from
availability are often due to patent litigation and other 19% to 1% until uptake of biosimilars increased.
logistical issues.
Notes: Biosimilar efficiency measures biosimilar share of market volume where biosimilars are approved and launched and for this exhibit is calculated based
on defined daily doses (DDDs) (see Definitions page).

Since 2007, 30 biosimilars have launched in the U.S. with 10 more

approved and set to launch by the end of 2023
Exhibit 5: Biosimilars approved and launched in the U.S.
somatropin 1
filgrastim 1 2 3 4
infliximab 1 2 3 4
insulin glargine 1 2 3
insulin lispro 1
pegfilgrastim 1 2 3 4 5 6
epoetin alfa 1
bevacizumab 1 2 3 4
trastuzumab 1 2 3 4 5
rituximab 1 2 3
teriparatide 1
ranibizumab 1 2
adalimumab 1 2-7 8
Jan-07 Jan-13 Jan-14 Jan-15 Jan-16 Jan-17 Jan-18 Jan-19 Jan-20 Jan-21 Jan-22 Jan-23
Launched biosimilars Approved biosimilars not yet launched Launch not announced
Source: IQVIA Institute, Dec 2022.
• In the United States, the Biologics Price Competition • Generally, biosimilars distributed at pharmacies
and Innovation Act (BPCIA) enacted in 2010 created require approval from the prescriber to be substituted
the 351(k) pathway for biosimilars, however the first for the reference product; however, the FDA granted
biosimilar was not approved through this pathway interchangeability for the first time in 2021 to Semglee
until 2015. Some biosimilars were approved through (insulin glargine), and since then two additional
the 505(b)(2) pathway for abbreviated approvals of biosimilars have received interchangeability status
non-original products referencing another product, with additional applications pending with the FDA.
and others were submitted as an original biologics This allows pharmacists to substitute biosimilars
license application under the 351(a) pathway. without going back to the prescriber for approval.
• The U.S. FDA has approved 45 biosimilars across 14 • Although it is still unclear how interchangeability will
molecules (etanercept not shown above) since 2006, impact the use of biosimilars, it allows pharmacists
with 30 of these products launched and 12 molecules to more easily substitute biosimilars for originator
facing biosimilar competition as of the end of 2022. products similar to how they are able to substitute
generics for brands.
• By the end of 2023, at least 10 of the currently
approved biosimilars are expected to launch, with
eight of these being biosimilars for adalimumab
(Humira), which will lose exclusivity in January 2023.
Notes: Biosimilars approved but not yet launched are placed based on expected launch announced by company. Approved etanercept (Enbrel) biosimilars not
included as they are not expected to launch until 2029.
There are biosimilars approved or in clinical development in the

U.S. for 20 additional molecules
Exhibit 6: Cumulative molecule spending and approved, launched and pipeline biosimilar products for
the molecule
Cumulative spending 1997–2021 US$Bn Number of biosimilar drugs by status
0 25 50 75 100 165 -5 0 5 10 15
adalimumab
insulin glargine
etanercept
epoetin alfa
infliximab
pegfilgrastim
rituximab
insulin aspart
insulin lispro
interferon beta-1a
bevacizumab
ustekinumab
trastuzumab
aflibercept
liraglutide
pembrolizumab
somatropin
darbepoetin alfa
denosumab
ranibizumab
nivolumab
filgrastim
omalizumab
secukinumab
natalizumab
certolizumab pegol
golimumab
teriparatide Molecules with launched biosimilars Discontinued
cetuximab
pertuzumab
ipilimumab Molecules with no launched biosimilars Launched
tocilizumab
peginterferon alfa-2a Approved but not launched
follitropin alfa
eculizumab Phase I to pre-reg
ramucirumab
imiglucerase
pegaspargase Pre-clinical to discovery
idursulfase
Source: IQVIA MIDAS, Dec 2021; IQVIA Pipeline Intelligence, IQVIA Institute, Dec 2022.
• Currently there are 39 molecules with biosimilars • Nine molecules with biosimilar development have
approved or in the pipeline. Within these, 30 molecules attracted five or more biosimilar competitors, while
have biosimilars in clinical development (Phase I to pre- the remaining molecules have attracted fewer.
registration), 12 molecules have biosimilars launched,
• The magnitude of molecule sales and the number of
and two molecules have biosimilars approved but not
biosimilars in development is not always correlated,
launched, as they are still patent-protected.
rather it appears that the selection of molecules for
• Biosimilars launched thus far generally have been for biosimilar development may be influenced by multiple
molecules with significant lifetime spending at invoice factors such as technical complexity or intellectual
levels, with adalimumab and etanercept being the property issues.
two largest molecules by spending with no biosimilar
• Only two molecules with less than $1Bn in cumulative
competition, as these products are still protected.
sales, pegaspargase (Oncaspar) and idursulfase
• Although insulins have generated significant sales at (Elaprase), have biosimilars in development. Both of
invoice levels, few biosimilars have launched or are in these are indicated for rare diseases, where different
development for these molecules. This is, in part, due market dynamics are at play potentially attracting
to complexities of manufacturing insulin and deep biosimilar developers.1
market discounts that limit potential financial returns.
Notes: For products with known understated sales in IQVIA MIDAS, sales values are reported from public sources. Pipeline includes biosimilar medicines with
development programs in the United States or other developed markets with regulatory filings in the United States or publicly stated intent to do so.

For molecules facing biosimilars, competitiveness is highly varied

but large share for later competitors is rare
Exhibit 7: Market concentration Herfindahl-Hirschman Index and shares by competitor Q3 2022
Higher market insulin lispro insulin glargine infliximab bevacizumab somatropin trastuzumab Lower market
concentration 0.86 0.57 0.42 0.38 0.33 0.27 concentration
(Fewer and/ (many and/
or disparate or similar
sized competitors) sized competitors)
Illustrative Illustrative
1.0 0.0
ranibizumab teriparatide epoetin alfa pegfilgrastim filgrastim rituximab

0.99 0.69 0.61 0.38 0.34 0.32
Originator Biosimilar 1 Biosimilar 2 Biosimilar 3 Biosimilar 4 Biosimilar 5
• As stakeholders consider the impact of biosimilar • Ranibizumab has the highest HHI score, as biosimilars
competition, a common measure of competitiveness just launched in the most recent quarter. Insulin lispro
in a market is the Herfindahl-Hirschman Index (HHI), has the second highest HHI score (0.86), as there is
which assesses the number of competitors (including only one biosimilar competitor, and the originator
the originator) and the market share each achieves to launched an authorized generic, effectively blunting
provide a more nuanced view of market dynamics. biosimilar uptake.
• In sustainable competitive markets, more competitors • To date, being first or second to launch has generally
divide the market more evenly, achieving a low HHI been a significant advantage.
score, while monopolies have a score of 1.0.
• In the future, especially in medicines with larger
• For molecules with biosimilar competition, their spending, pricing impacts may still be driven by third-
HHI scores range from 0.27 to 0.99. Trastuzumab or-later entrants, as they may seek more aggressive
has the lowest concentration of share across the contracting and discounting.
six competitors, suggesting it is currently the most
• Overall, biosimilar savings will be limited if fewer
sustainable market.
molecules attract large numbers of competitors.
Notes: The Herfindahl-Hirschman Index (HHI) is defined as the sum of the squares of market shares (see Definitions). Calculations are based on defined daily
dose shares where each medicine is normalized to a standardized dose per day to adjust for formulation differences between originators and biosimilars.
Authorized generics are those medicines marketed or authorized by the originator using non-proprietary naming but are the same as the originator product
and included in the originator share. Somatropin has six originator products.
Development of biosimilars is being driven by smaller companies,

while marketing is done mostly by large companies
Exhibit 8: Biosimilars in development and marketed in the U.S. by company type and size
Biosimilars in development Marketed biosimilars by company type and size

n = 118 n = 30
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Developer Marketer
Large pharma Other
Source: IQVIA Global Biosimilars Database, Sep 2022; IQVIA Institute, Nov 2022.
• Currently, 21% of the biosimilar products in the • Seven products have been developed and launched by
pipeline are being developed by large pharma smaller companies, either partnering with each other
companies (those with more than $10Bn in global or going alone, highlighting the likelihood that the
sales). The remaining 79% are being developed by complexities and costs of marketing biosimilars are
smaller companies with varying degrees of biologic or likely filtering out smaller competitors.
biosimilar development experience.
• While larger companies have historically marketed
• Of biosimilar products marketed in the United States, the majority of biosimilars, this has shifted some
19 were developed and launched by seven large with recent and upcoming launches. In 2020, smaller
pharma companies: Pfizer developed and launched companies had marketed only 9% of biosimilars, while
six (three acquired in the 2015 Hospira acquisition), this has grown to 23% in 2022 and is likely to grow to
Amgen developed and launched four, and Viatris and 30% in 2023 based on expected launches.
Sandoz have developed and launched three each.
• There are six biosimilar products that were developed

by companies that focus specifically on biosimilar
development yet were marketed by large pharmas.
The most prolific developer is Celltrion, which
developed three biosimilars. Two of the products were
commercialized by Teva, and the third by Pfizer.
Notes: Large pharma are those with >$10 billion global pharmaceutical sales. Other refers to all other companies with a biosimilar in development, regardless
of biologic or biosimilar experience.

Factors influencing biosimilar uptake
• Recent biosimilars have achieved high volume shares, • Providers participating in the Oncology Care Model
reaching more than 60% of the molecule’s volume adopted biosimilars at higher levels compared to
within the first three years. Non-340B clinics have seen non-participants, highlighting how patient care
higher uptake of biosimilars than 340B clinics, likely models can impact reimbursement and potentially
due to reimbursement dynamics. provide incentives for increasing the adoption of
biosimilars.
• The utilization of biosimilars has dramatically changed
since 2020. For example, most providers are now using • Biosimilar penetration at pharmacies, which so far
a biosimilar of bevacizumab more than the originator relates only to insulin glargine and insulin lispro,
and few still favor the originator. has remained relatively low. The introduction of
interchangeable biosimilars and authorized generics
• Biosimilar utilization can be influenced by how it is
has influenced the ability of biosimilars to gain
distributed and reimbursed. Biosimilars have had
market share.
stronger uptake in buy-and-bill, where physicians have
incentive to select one product over another.
• Biosimilar products were more readily adopted among

professional providers in the first year after launch
compared to institutional providers, but use was at
similar levels after two years, with differences in setting
and reimbursement likely impacting the rate of uptake.
Molecules with biosimilars first launched in 2019 have seen significant

biosimilar uptake in the last three years, though variability still exists
across care settings in the use of biosimilars.
Recent biosimilars have achieved high volume shares, reaching

more than 60% within the first three years, varying by channel
Exhibit 9: Biosimilar share of volume since biosimilar launch
90% Biosimilar share of days in DDDs 100% Biosimilar share of volume units
82% 90% since bevacizumab biosimilar launch
80% 86%
80%
70% 80% 79%
67%
70% 73%
60% 60%
60%
50%
50%
40%
37% 40%
30%
30%
20% 19% 20%
1%
13%
10% 10%
0% 0%
0 2 4
6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36
Months since biosimilar introduction Months since biosimilar introduction
bevacizumab 7/2019 filgrastim 11/2013 teriparatide 6/2020 Non-340B clinics 340B
trastuzumab 7/2019 pegfilgrastim 7/2018 infliximab 11/2016 Overall All others
rituximab 11/2019 epoetin alfa 9/2018 ranibizumab 7/2022
Source: IQVIA MIDAS, IQVIA DDD, Oct 2022; IQVIA Institute, Dec 2022.
• The three molecules with biosimilar launches in • Infliximab has seen the lowest adoption of biosimilars,
2019 — bevacizumab (82%), trastuzumab (80%), and with volume share at 3% after one year and rising
rituximab (67%) — achieved significant uptake within slowly to 13% after three years. This has shifted
the first three years. It is unclear if uptake of these significantly in more recent years as biosimilars now
recent oncology biosimilars is indicative of future account for 44% of infliximab volume nearly six years
biosimilar uptake, however these have gained higher after biosimilar entry (not shown).
market share than earlier biosimilars in the U.S. and
• Biosimilar bevacizumab adoption has been consistently
are similar to or higher than rates of uptake in Europe. 2
higher in clinics not eligible for 340B discounts and
• Pegfilgrastim and epoetin alfa biosimilars, both may be the result of a strategic approach by biosimilar
launched in 2018, have seen moderate uptake achieving companies to prioritize contracting with these outlets.
37% share of molecule volume in the first three years.
• Uptake of biosimilar in 340B clinics has continued to
Pegfilgrastim biosimilar share has continued to rise
rise but remains lower than non-340B clinics, likely
slowly (see Exhibit 16) while epoetin alfa biosimilar
the result of pricing and reimbursement dynamics
share has fallen to 27% as of October 2022.
between originator and biosimilar products.
Notes: Bevacizumab share in right chart is volume unit shares without days of therapy normalization, resulting in differences in overall share compared to
DDD-based calculations in left chart. Biosimilars for pharmacy benefit drugs (insulins) are discussed in Exhibit 14.

Most providers are using a biosimilar of bevacizumab more than

the originator, with few favoring the originator
Exhibit 10: Use of biosimilars and originator bevacizumab within outlets
Originator and biosimilars share of Top 100 highest-volume outlets

bevacizumab volume distributed for bevacizumab 2020 vs. 2022
Share of national bevacizumab volume units
to outlets 2020 vs. 2022

60% 100%
90%
Biosimilar share of outlet

50% 80%
40% 70%
60%
30% 50%
40%
20% 30%
20%
10%
10%
0% 0%
0 10 20 30 40 50 60 70 80 90 100
%
0%
0%
0%
0%
0%
0%
0%
0%
%
00
10
–2
–3
–4
–5
–6
–7
–8
–9
Higher volume Lower volume

–1
0–
11
21
31
41
51
61
71
81
Outlet volume rank 1-100

91
Lower share Higher share

Biosimilar share of outlet
Originator 2022 Biosimilars 2022 Biosimilar share 2020 Biosimilar share 2022
Originator 2020 Biosimilars 2020
Source: IQVIA DDD, Oct 2022; IQVIA Institute, Dec 2022.
• Bevacizumab biosimilars have had the highest • Among the top 100 provider groups, which account
adoption of any biosimilar launched in the U.S., with for 24% of overall bevacizumab volume, only 12 utilize
most high-volume providers favoring biosimilars. biosimilars less than half the time, a significant shift
from 2020 when 73 utilized biosimilars less than half
• The utilization of bevacizumab biosimilars has
the time.
dramatically changed over the last two years, with only
17% of volume going to outlets that used biosimilars • Few high-volume outlets still favor the originator
less than half the time in 2022 compared to 70% in 2020. and those that do are likely a result of contracting or
provider preferences.
• Nearly 60% of total bevacizumab volume is distributed
to outlets that use biosimilars more than 90% of the • While bevacizumab biosimilars have seen significant
time, accounting for 72% of biosimilar volume. uptake, it is unclear if similar shifts in uptake and
volume distribution will occur in other therapy areas
• Bevacizumab has seen significant shifts in product
and distribution channels.
use across high-volume providers, with most
favoring biosimilars in 2022 while more favored
originators in 2020.
Notes: 2022 outlet biosimilar shares and volume calculated using YTD Oct 2022 data. 2020 outlet biosimilar shares and volume previously published in the
IQVIA Institute report Biosimilars in the United States 2020-2024. Outlet level details such as outlet name and location are confidential. Top 100 combines
corporate parents and excludes multi-doctor/practice group purchasing organizations. Top 100 outlets are the highest volume outlets in 2020 and 2022 and
may not represent the same outlets.
Biosimilars have had stronger uptake in buy-and-bill, where

physicians have incentive to select one product over another
Exhibit 11: Average biosimilar new patient market share over time by billing type
90% White-bagged 90% Buy-and-bill
80% 80%
70% 70%
% of new-to-brand patients
57%
60% 60% 54% 55% 55% 56%
50% 50% 47% 47%
45%
39%
40% 35% 40%
31% 32% 31%
30% 27% 27% 30%
22% 23% 22%
20% 15% 20%
12%
8% 9%
10% 4% 10%
0% 1% 0%
0% 0%
0 2 4 6 8 10 12 14 16 18 20 22 24 0 2 4 6 8 10 12 14 16 18 20 22 24
Months since launch Months since launch
Average (n=6) By molecule
Source: IQVIA LAAD Medical Procedures Claims, Sep 2022; US Market Access Strategy Consulting, Dec 2022.
• How a drug is distributed can also have an impact on • When drugs are obtained through buy-and-bill
the relative usage of biosimilars. In the case of white and providers may benefit from potential high
bagging, where pharmacies manage acquisition and reimbursement rates compared to acquisition costs
distribution, vs. buy-and-bill, where providers manage with biosimilars, biosimilars have achieved 57% on
acquisition and distribution, significant differences in average of new patient market share after two years.
biosimilar uptake exist.
• In white bagging, where product acquisition and
• Based on a survey of commercial plans, buy-and-bill is reimbursement is managed by the pharmacy
the most frequently used method of drug acquisition and therefore subject to pharmacy benefit plans,
although the use of white bagging has grown in recent biosimilars are utilized significantly less, achieving 35%
years, particularly in physician offices. 3
market share after two years, highlighting the fact that
providers have less incentive to choose a biosimilar in
this case.
Notes: Evaluated biosimilars include bevacizumab, epoetin alfa, trastuzumab, pegfilgrastim, infliximab, and rituximab.

Biosimilar products were more readily adopted among professional

providers compared to institutional
Exhibit 12: Average biosimilar new patient market share over time by provider type
100% Institutional 100% Professional

90% 90%
80% 80%
70% 70%
57% 57% 58% 59% 60%
60% 53% 52% 53% 55% 60%
48% 49% 50% 50%
50% 43% 44% 50% 45%
38%
40% 40% 36%
31%
30% 30% 28%
23%
20% 13% 20%
14%
10% 10%
0% 2% 1%
0% 0%
0 2 4 6 8 10 12 14 16 18 20 22 24 0 2 4 6 8 10 12 14 16 18 20 22 24
• The setting in which patients receive care can also • While motivations of stakeholders are complex,
influence the utilization of biosimilars vs. originators. institutional settings are more likely to embed
Institutional providers — those in hospitals, skilled contracting and reimbursement structures — such
nursing facilities, and other similar settings — and as group purchasing organizations, accountable
professional providers — those primarily in physician care organizations, and 340B — that influence
offices — may favor one product or another based on adoption of biosimilars.
contracting and reimbursement.
• In professional settings, biosimilars have had a

somewhat rapid uptake, reaching 36% of new patient
market share after six months and 50% after 12
months, and uptake slowing to 60% after two years.
• Although eventually reaching similar levels of uptake in

institutional settings after two years, these providers
have adopted biosimilars at a slower rate than their
professional counterparts. Biosimilars achieved 23% of
new patient market share in institutional settings after
six months, 43% after 12 months, and growing to 55%
after two years.
Notes: Evaluated biosimilars include bevacizumab, epoetin alfa, trastuzumab, pegfilgrastim, infliximab, and rituximab.
Providers participating in the Oncology Care Model adopted

biosimilars at higher levels compared to non-participants
Exhibit 13: Average oncology biosimilar new patient market share over time by provider OCM status
100% OCM participant 100% Other

90% 90%
80% 77% 76% 80%

73% 75% 75%
70% 65% 70% 64%
61% 62% 60% 61% 60% 62%
60% 60%
53% 54%
49% 49%
50% 50%
39% 42%
40% 40% 34%
30% 27% 30% 25%
20% 20%
12% 10%
10% 10%
0% 1%
0% 0%
0 2 4 6 8 10 12 14 16 18 20 22 24 0 2 4 6 8 10 12 14 16 18 20 22 24
• The Centers for Medicare & Medicaid Services (CMS) • The differences in uptake were likely driven by the
ran the Oncology Care Model (OCM) from 2016 until incentives for OCM participants to reduce costs,
2022, with the objective of reducing Medicare costs and OCM practices noted that utilizing lower-cost
and improving quality of care in cancer patients. OCM biosimilars was a relatively easy method for reducing
participants covered one-fourth of Medicare FFS costs per treatment.5
chemotherapy-related cancer care practices.4
• Although the OCM ended in 2022, it will be succeeded
• OCM participants adopted biosimilars at significantly by the Enhancing Oncology Model in 2023 with similar
higher levels than non-participants, with average goals and potentially additional focus on biosimilar
biosimilar uptake at 76% after two years in the OCM adoption by participants through inclusion of drug
and 64% in other practices. spending in performance-based payments.
• When only looking at biosimilars launched in 2019, • The OCM highlights how patient care models can
the difference is even more striking, with average impact reimbursement and potentially provide
biosimilar uptake at 92% in OCM participants and still incentives for increasing the adoption of biosimilars.
high but lower at 77% in non-participants.
Notes: Evaluated biosimilars include oncology and supportive care related molecules: bevacizumab, epoetin alfa, trastuzumab, pegfilgrastim, and rituximab.

Interchangeability has increased biosimilar use where biosimilar

uptake has remained low due to originator defense strategies
Exhibit 14: Insulin monthly share of defined daily doses (DDDs) by product, Jan 2016–Nov 2022
Insulin glargine Insulin lispro

Unbranded interchangeable biosimilar
100% 100%
Admelog 8%
90% Basaglar 90%
Semglee 28% Authorized
80% 80% generic
70% Toujeo 70%
Share of DDDs
Lyumjev
60% 60%
50% 50%
Authorized Humalog
40% generic 40%
30% Lantus 30%
20% 20%
10% 10%
0% 0%
6
16
18
20
22
16
18
20
22
-1
-1
-1
-1
-2
-2
-2
-1
-1
-1
-1
-2
-2
-2
p-
p-
p-
p-
p-
p-
p-
p-
Jan
ay
Jan
ay
Jan
ay
Jan
Jan
ay
Jan
ay
Jan
ay
Jan
Se
Se
Se
Se
Se
Se
Se
Se
M
M
Source: IQVIA MIDAS, Nov 2022; IQVIA Institute, Jan 2023.
• With biosimilars for pharmacy-reimbursed drugs, • Viatris launched Semglee, the second insulin glargine
which to date include insulin glargine and insulin lispro, biosimilar, in 2020, capturing only 1–2% of the market
pharmacy benefit managers (PBMs) play a significant in the first year. After receiving interchangeability in
role in coverage and reimbursement decisions. 2021, Viatris launched an unbranded interchangeable
biosimilar in addition to branded interchangeable
• The uptake of insulin biosimilars has remained low,
Semglee. These two interchangeable insulins now
with insulin glargine biosimilars achieving 28% share
account for 8% of volume, taking volume from both
in 2022, six years after launch, and insulin lispro
Basaglar and the originators, with pay type influencing
biosimilars 8% in 2022, nearly four years after launch.
use of interchangeable biosimilar.6
Although low, these are similar to biosimilar insulin
uptake in Europe. 2 • Biosimilar insulins have additionally faced ‘authorized
generics’ launched by the originators with a lower cost
• Insulin glargine has a variety of products competing
than the brand (likely without confidential rebates),
in the market with originator Lantus and its higher
and this has played a major role in the insulin lispro
concentration version, Toujeo, still accounting for most
market (21% of volume) but less so in insulin glargine
of the volume.
(1% of volume).
Notes: Authorized generics are those medicines marketed or authorized by the originator using non-proprietary naming but are the same as the originator
product. Toujeo is a higher concentration version of Lantus. Basaglar is a biosimilar approved through the 505(b)(2) pathway. Semglee is a biosimilar
approved through the 351(k) pathway; Viatris launched an unbranded interchangeable version in 2021. Lyumjev is an originator launched product of insulin
lispro with additional inactive ingredients that allow it to absorb more quickly than Humalog. Admelog is a biosimilar approved through the 351(k) pathway.
Biosimilar impacts on molecule volume and price
• The introduction of biosimilars frequently leads to • Absolute savings from biosimilars vary, with larger
higher utilization of the molecule as lower costs savings where originators were more costly, including
offer increased access to patients. However, more 2019 biosimilar launches, which have seen ASP
innovative alternative treatments can lead to volume reductions of $2,526–$4,913, potentially a factor in
declines as patients are moved to these successive their high uptake.
generation products.
• The volume maintained by originators after facing
• Patient access to successive generations of originator biosimilar competition is correlated with the relative
products has narrowed the market ultimately price reduction in the originator product compared
accessible to biosimilars, impacting the potential to the biosimilar. Generally, originators which
financial returns for biosimilar developers. have reduced prices to similar levels as biosimilar
competitors have lost less volume following biosimilar
• Introduction of lower cost biosimilars leads to declines
entry, while originators maintaining higher prices see
in overall molecule costs per unit (i.e., includes
significant volume loss.
originator and biosimilars) at invoice prices over time,
typically driving down costs for originators as well.
Introduction of biosimilars frequently leads to increased access of a

biologic medicine to patients driven by lower costs of biosimilars and
price reductions of originators.

BIOSIMILAR IMPACTS ON MOLECULE VOLUME AND PRICE
Introduction of biosimilars frequently leads to increased use,

however innovative treatments can lead to volume declines
Exhibit 15: Incremental volume after biosimilar entry compared to prior trend
2 filgrastim 100 infliximab 500 insulin glargine 250 insulin lispro 10 pegfilgrastim
1.5 80 400 200 8
+14% -1% +26%
-12%
60 300 150 6
1
Defined daily doses (millions)
+154% 40 200 100 4

0.5 100 50 2
20
0 0 0 0 0
-12 -6 0 6 12 18 24 30 -12 -6 0 6 12 18 -12 -6 0 6 12 18 -12 -6 0 6 12 18 -12 -6 0 6 12
80 epoetin alfa 4 bevacizumab 8 trastuzumab 3 rituximab 3 teriparatide
+7% -30% 2.5 2.5
60 3 6 -17%
+9% 2 2 +113%
40 2 4 1.5 1.5
1 1
20 1 2
0.5 0.5
0 0 0 0
-12 -6 0 6 12 -12 -6 0 6 12 -12 -6 0 6 12 -12 -9 -6 3- 0 3 6 9 -12 -9 -6 -3 0 3 6 9
Quarters since biosimilar launch
Actual molecule volume
Methodology illustration
Projected molecule volume 0.02 Pre-expiry volume trend Percentage change
% Change in volume compared 0.15 Biosimilar volume in volume after
with pre-expiry trend biosimilar entry
0.10 compared with
0.05 Originator volume pre-expiry volume
0 trend
0 1 2 3 4
• Biosimilars represent the potential for significant • Insulins have seen less incremental volume following
savings, while also offering increased access to cost- biosimilar entry, suggesting competitive dynamics
sensitive patients. As a result, whole molecule volume within the insulin space and the introduction of
is expected to grow when biosimilars are introduced. innovative diabetes treatments.
Comparisons between the molecule volume trend pre-
• Cancer treatments trastuzumab and rituximab have
and post-biosimilar entry indicate there are complex
not seen volume growth from biosimilars due to
dynamics at play.
the impacts of successive generations of innovative
• As biosimilars become available, most molecules have treatments, with pertuzumab (Perjeta) and trastuzumab
seen incremental volume ranging from +7% to +154% antibody-drug conjugates impacting trastuzumab
but there are notable cases where incremental volume volume (see Exhibit 16) and subcutaneous rituximab
has been flat or declining, ranging from -1% to -30%. (Rituxan Hycela) modestly impacting rituximab.
• Filgrastim and pegfilgrastim have both seen • Teriparatide was seeing declining volume since the
incremental volume despite competing with each introduction of denosumab in osteoporosis in 2010
other. There is a clear pattern of incremental volume (-66% through mid-2020), however volume growth has
shifting to the cheaper and shorter-acting filgrastim stabilized and slightly risen since biosimilar entry in
biosimilars until 2018, when pegfilgrastim biosimilars mid-2020.
became available (see Exhibit 16).
Notes: Pre-expiry volume trend is based on three years prior to biosimilar entry. Change in volume is calculated comparing the molecule total volume to the
expected volume from the pre-expiry trend.
Patient access to successive generations of originator products has

narrowed the biosimilar-accessible market
Exhibit 16: Quarterly share of defined daily doses (DDDs) by originators, second generation originators, and
biosimilars in the U.S.
100% 100%
90% 90% Perjeta
Phesgo
80% pegfilgrastim biosimilars 80% Enhertu
70% 70%
Share of DDDs
60% 60% Kadcyla
50% Neulasta* 50%

40% 40%
Herceptin*
30% 30%
20% 20% trastuzumab biosimilars
filgrastim biosimilars
10% Neupogen* 10%
0% 0%
10
11
12
13
14
15
16
17
18
19
20
21
22
98
00
02
04
06
08
10
12
14
16
18
20
22
20
20
20
20
20
20
20
20
20
20
20
20
20
19
20
20
20
20
20
20
20
20
20
20
20
20
• Taking a longer-term view of the volume of two • The group of products in breast cancer, while not a
markets as examples, newer-generation medicines can full view of all breast cancer treatments, illustrates the
supersede the first originator and change the size of market accessible to trastuzumab biosimilars has been
the market ultimately accessible to biosimilars. reduced by over 20% as newer generation products
have increasingly been adopted prior to and following
• As biosimilar makers identify and prioritize molecules
the introduction of biosimilars in 2019.
to develop, the size of the accessible market is a critical
factor in determining potential financial returns and • The recent passage of the Inflation Reduction Act
their strategy. The accessible market may fluctuate due introduces additional uncertainty into the biologic and
to shifts in volume, lower costs that increase access, or biosimilar markets as multiple aspects of the legislation
increased adoption of newer innovative products. could influence stakeholders’ product preferences,
including patients, purchasers, and developers.
• In the colony-stimulating factor market, the shift from
filgrastim to pegylated filgrastim (pegfilgrastim) has
been underway for many years, yet slightly reversed
with the launch of biosimilars as volume shifted
back to filgrastim. This shift has reversed since the
introduction of pegfilgrastim biosimilars.
Notes: *Originator product where biosimilars are available for the same molecule: filgrastim (Neupogen), pegfilgrastim (Neulasta), trastuzumab (Herceptin).
Trastuzumab emtasine (Kadcyla) and trastuzumab deruxtecan (Enhertu) are antibody-drug conjugates. Pertuzumab (Perjeta) is a newer generation breast
cancer drug not currently facing competition. Pertuzumab/trastuzumab/hyaluronidase (Phesgo) is a fixed-dose combination of Perjeta and Herceptin in a
single subcutaneous injection. Herceptin includes Herceptin Hylecta a subcutaneous form of trastuzumab launched in 2019.

Introduction of a biosimilar has driven down total molecule costs

18–50% with rate of decline driven by biosimilar uptake
Exhibit 17: Change in cost per extended unit following biosimilar launch relative to pre-expiry cost
20%
Change in cost per extended unit relative to
one month prior to biosimilar launch
10%
0%
-10%
-18% -21%
-20%
-30% -31%
-40%
-42%
-43% -44%
-50% -50%
-60%
0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84
Months post-biosimilar launch
bevacizumab epoetin alfa filgrastim infliximab pegfilgrastim rituximab trastuzumab
Source: IQVIA National Sales Perspective, US Market Access Strategy Consulting, Dec 2022.
• Introduction of lower cost biosimilars leads to declines biosimilar, launched nearly two years later costs began
in overall molecule costs per unit (i.e., includes to fall and dropped 31% from this peak over the next
originator and biosimilars) at invoice prices over time, five years.
typically driving down costs for originators as well.
• Infliximab which saw relatively slow biosimilar uptake
• Costs are down between 18% and 50% per unit for initially (see Exhibit 9) had relatively slow cost per
molecules with biosimilars, with epoetin alfa having unit declines following biosimilar entry. Increases in
the smallest decline at present and infliximab having biosimilar uptake and the increased use of the less
the largest. expensive authorized generic have led to a 50% decline
in costs nearly six years after biosimilar entry.
• Bevacizumab and trastuzumab have had the most
rapid decline in cost per unit, primarily due to the • Epoetin alfa which had been declining in cost per
significant biosimilar uptake driving down molecule unit at the molecule level has seen declining use of
level costs (see Exhibit 9). biosimilar in favor of the originator in recent months,
while the originator product has been rising in invoice
• Filgrastim saw rising costs per unit following initial
prices. However, epoetin alfa costs are still down 18%
biosimilar entry, with costs rising up to 10% compared
from pre-expiry costs.
to pre-expiry. When Zarxio, the second filgrastim
Notes: Costs are based on spending at ex-manufacturer invoice prices and do not include off-invoice discounts and rebates. Extended units represent number
of milliliters for wet vials or pre-filled syringes and number of vials for dry vials. Trastuzumab and infliximab come in varying strengths of dry vials and
extended units were normalized to the amount of active ingredient per extended unit.
Absolute savings from biosimilars vary, with larger savings where

originators were more costly
Exhibit 18: Originator and mean biosimilar Average Sales Price (ASP) in US$, Oct 2022
ASP price difference

filgrastim -$210.64 (-62.9%)
-$1,547.04 (-53.3%) or -$1,674.75
infliximab (-57.7%) for authorized generic
Order of biosimilar launch
-$69.70 (-20.6%) or -$182.79

insulin glargine (-53.9%) for authorized generic
-$283.69 (-60.9%) or -$316.85
insulin lispro (-18.2%) for authorized generic
pegfilgrastim -$2,852.79 (-60.9%)
epoetin alfa -$28.98 (-33.7%)
bevacizumab -$4,913.48 (-57.6%)
trastuzumab -$2,526.39 (-56.2%)
rituximab -$3,050.61 (-50.4%)
teriparatide -$873.95 (-27.3%)
ranibizumab -$547.72 (-31.3%)

Absolute and percentage
price difference between $0 $1,000 $2,000 $3,000 $4,000 $5,000 $6,000 $7,000 $8,000 $9,000
originator pre-expiry and Originator pre-biosimilar Biosimilar average
biosimilar average sales price
Source: CMS ASP Oct 2022, accessed Dec 2022; IQVIA National Sales Perspectives, Oct 2022; IQVIA Institute, Dec 2022.
• The three biosimilars launched in 2019, bevacizumab, • For pharmacy products, average invoice prices are
trastuzumab, and rituximab, have seen ASP price often closest to the price patients pay during their
reductions of $2,526–$4,913 for a standard course of deductible, notwithstanding pharmacy markups.
treatment, potentially a factor in the high uptake of
• Since insulin glargine biosimilar Basaglar launched,
these biosimilars. These also had some of the highest
invoice prices have declined only 21%, meaning
pre-expiry prices of molecules with biosimilars.
patients have saved less to date from the advent of
• As ASP-based reimbursement is used in Medicare Part biosimilar insulins compared with biosimilars for other
B and in some commercial plans, this analysis shows molecules. However, the authorized generic for insulin
an ASP cost comparison as an indicator of the burden glargine launched by the originator is 54% below pre-
and/or savings biosimilars offer to payers. Though expiry prices, highlighting the impact these products
patient cost-sharing models differ, patients typically can have on biosimilar competitiveness.
pay 20% of Medicare costs.
Notes: Average sales price (ASP) calculated from CMS website using Oct 2022 and period pre-biosimilar entry for each medicine, accessed Dec 2022. Insulins
and teriparatide use IQVIA invoice prices, as well as ranibizumab as biosimilar ASP was not available for ranibizumab as of Oct 2022. ASP prices normalized to
standardized dosing for each medicine: filgrastim 5mcg/kg, insulin glargine and insulin lispro 5 pen pack 100units/ml 3ml, infliximab 5mg/kg, pegfilgrastim
6mg per chemotherapy cycle, epoetin alfa 100 units/kg, bevacizumab 15mg/kg, trastuzumab 6mg/kg, rituximab 375mg per meter-squared body surface area,
teriparatide one pre-filled syringe (28 daily doses), ranibizumab 0.5mg dose. Standard body weight was considered 70kg and standard body surface area 1.7
meters squared.

Originators lose more volume when maintaining prices higher than

biosimilar competitors
Exhibit 19: Change in originator Average Sales Price (ASP) in US$ and volume
Originator and biosimilar ASP price Originator volume change

change pre-biosimilar vs. Oct 2022 pre-biosimilar vs. Q3 2022
filgrastim 3% -86%
-63%
infliximab -58% -31%

-53%
Order of biosimilar launch
pegfilgrastim -66% -36%

-61%
epoetin alfa -32% -34%
-34%
-14% -80%
bevacizumab -58%
trastuzumab -21% -85%

-56%
rituximab -13% -69%

-50%
teriparatide 0% -20%
-27%
ranibizumab -8% -16%
-31%
-80% -60% -40% -20% 0% 20% -100% -80% -60% -40% -20% 0%
Originator percent change Biosimilar percent savings
Source: CMS ASP Oct 2022, accessed Dec 2022; IQVIA National Sales Perspectives, Oct 2022; IQVIA MIDAS, Sep 2022; IQVIA Institute, Dec 2022.
• The volume maintained by originators after facing • The originator for filgrastim has maintained an ASP
biosimilar competition is correlated with the relative that is 66% higher than biosimilar competitors and
reduction in the originator product compared to the has increased prices since pre-expiry; consequently,
biosimilar. Generally, originators who have reduced the originator has lost 86% of volume compared to
prices to similar levels as biosimilar competitors have pre-expiry.
lost less volume following biosimilar entry.
• Similarly, originators that faced biosimilar competition
• Infliximab, pegfilgrastim, and epoetin alfa originators beginning in 2019 — bevacizumab, trastuzumab, and
have all reduced prices to less than or similar to their rituximab — have maintained ASP significantly higher
biosimilar competitors and have lost less volume than biosimilars resulting in significant volume loss for
compared to originators for other molecules. these originators.
Notes: ASP from CMS website for Oct 2022 and period pre-biosimilar entry for each medicine, accessed Dec 2022. ASP dosing normalized to standard dosing.
Filgrastim 5mcg/kg, insulin glargine and insulin lispro 5 pen pack 100units/ml 3ml, infliximab 5mg/kg, pegfilgrastim 6mg per chemotherapy cycle, epoetin
alfa 100 units/kg, bevacizumab 15mg/kg, trastuzumab 6mg/kg, rituximab 375mg per meter-squared body surface area, teriparatide one pre-filled syringe (28
daily doses), ranibizumab 0.5mg vial. Standard body weight 70kg, standard body surface area 1.7 meters squared.
Future impacts of biosimilars
• Future biosimilar sales and savings will depend on a • The immunology market has seen significant growth
variety of market dynamics. To model this, volume in both spending and volume in the last five years and
uptake scenarios have been developed including high, the entry of new immunology biosimilars in 2023 will
medium, and low, tied to both originator competition increase competition in this rapidly growing market.
and price reductions ranging from 15–45%.
• The best-selling biopharmaceutical in the U.S.,
• Expected launches and uptake are likely to increase adalimumab (Humira), will face biosimilar competition
overall spending on biosimilars significantly to beginning in 2023, and product characteristics
$20–$49Bn in 2027 and cumulative sales of $129Bn and reimbursement decisions are likely to impact
over the next five years, with at least 10 molecules biosimilar uptake.
facing biosimilar competition over the period.
• With biosimilars seeing increasing acceptance in the
• Savings over the next five years as a result of U.S. and the scale of spending on medicines facing
biosimilars are projected to exceed $180Bn, though upcoming biosimilar competition increasing, the
uncertainties remain as market events to date suggest impact on all stakeholders will be significant.
a wide range of market outcomes are still possible.
Savings from biosimilars are expected to exceed $180Bn over the next five
years — a more than four-fold increase from the last five years — driven by
significant biosimilar launches in immunology, including for Humira.

FUTURE IMPACTS OF BIOSIMILARS
Volume uptake scenarios include high, medium and low, tied to both
originator competition and price reductions ranging from 15–45%
Exhibit 20: Modeling of scenarios based on average (base case), high and low examples to date
Biosimilar uptake assumptions ASP price reduction assumptions
70% 24
60%
50%
-15%
40%
30%
-30%
20%
10%
-45%
0%
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Low Base case High
Source: IQVIA MIDAS, Jun 2022; IQVIA Institute, Nov 2022.
• Future biosimilar sales and savings will depend on smaller but more profitable market segment but could
the market dynamics and behaviors of competing also be influenced by originator competitive actions
companies, negotiations with payers, and the actions and patient and provider preferences.
of patients and healthcare providers.
• Higher uptake (66% share at 24 months) is more likely
• Biosimilar uptake scenarios have been modeled based associated with aggressive discounting
on historic uptake of biosimilars, with the base case (e.g., a 45% price reduction), although the overall
representing average uptake across all marketed spending level on a medicine could make even small
biosimilars and high and low scenarios reflecting the discounts attractive to payers.
uptake of the best and worst performers.
• These scenarios represent the variety of market
• The base case scenario used for future projections dynamics expected in the future, with some molecules
estimates a 34% biosimilar share of molecule volume attracting more biosimilars who then offer aggressive
is achieved after 24 months along with a 30% price discounting, while other molecules may attract fewer
reduction compared to the originator. competitors with less aggressive strategies.
• A low volume uptake scenario (12% share at 24 months)

could occur if originator and biosimilar challengers find
that conceding less in discounts (15%) makes available a
Notes: High, low, and base case assumptions of biosimilar uptake in terms of volume and price discounts relative to originators are based on IQVIA Institute
analysis of historic analogues.
Expected launches and uptake are likely to increase overall

spending on biosimilars significantly to $20–49Bn in 2027
Exhibit 21: Biosimilar historical sales 2013–2022 and outlook scenarios 2023–2027, US$Bn
60
denosumab
50 omalizumab ramucirumab
Biosimilar sales, US$Bn
pertuzumab
ipilimumab 38.5
40
eculizumab 34.1
aflibercept
30 adalimumab 26.9
bevacizumab ustekinumab
trastuzumab tocilizumab
ranibizumab 18.1
20 ➔ somatropin rituximab
insulin lispro teriparatide
epoetin alfa 10.2 11.4
9.4
10 filgrastim insulin glargine pegfilgrastim 7.2
infliximab 4.6
1.2 2.6
0.1 0.3 0.4 0.4
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
Biosimilar sales range high/low Biosimilar sales base case
• Biosimilar sales over the next five years are expected • Each biologic medicine is attracting different numbers
to total $129Bn, ranging from $79Bn to $163Bn of competitors (see Exhibit 6), each potentially pursuing
depending on volume uptake and pricing discounts. aggressive strategies and facing originators who may
or may not compete to defend their market position.
• In the next five years, at least 10 molecules will face
biosimilar competition for the first time in the United • As an example, the three molecules facing 2019
States, including some of the highest-selling medicines biosimilar entry (bevacizumab, trastuzumab, and
such as adalimumab. rituximab) share the same originator manufacturer
(Roche/Genentech) and all have a similar trajectory of
• Biosimilar spending of $10.2Bn in 2022 is expected
challenger uptake, exceeding 60% by the end of three
to rise to over $38.5Bn in 2027 in the base case, with
years (see Exhibit 9).
scenarios ranging from $20Bn to $49Bn.
• As historical experience is an imperfect guide to future

market dynamics, these scenarios represent a range of
potential outcomes, and varied market dynamics are
possible in each molecule’s market.
Notes: Historical values are from IQVIA audits, and values for 2023–2027 are based on modeling of expected impact of in-progress biosimilar events and
projected future events. The range of biosimilar sales values shown in the outlook scenarios reflect assumptions for high, low, and average (base case)
biosimilar volume uptake and price discounts relative to originators. Timing of expected biosimilar entry based on patent information and litigation/
settlements as of Oct 2022.

Savings over the next five years as a result of biosimilars are

projected to exceed $180Bn, though uncertainties remain
Exhibit 22: Biologic estimated savings from biosimilars at invoice prices
5-year savings scenarios

60 $181Bn base case ($125-237Bn range)
Savings from biosimilars, US$Bn
50
42.9
41.0
38.8
40
33.0
30
25.5
20
13.2
10.7
10 7.9
5.2
3.4 2.9 2.9 3.0 3.0 3.3
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
Savings range high/low Savings base case
• In the last 10 years $36Bn of biosimilar spending was • Other significant biosimilar launches for high value
associated with savings of $56Bn compared to what ustekinumab in 2023 and aflibercept in 2024 are also
spending would have been without biosimilars. expected to contribute significantly to future savings.
• The next five years are expected to result in an • In addition to new biologic molecules facing biosimilars
increase in savings to $181Bn, more than four times from 2023–2027, recent biosimilars launched in 2018
savings over the past five years ($40Bn), as newly and 2019 are continuing to generate substantial
approved biosimilars launch and existing biosimilars savings as uptake increases and prices decline.
see continued uptake and price reductions.
• Market events to date suggest a wide range of market
• The most impactful biosimilars in the next five outcomes are still possible, ranging from lower
years — those referencing adalimumab — will first biosimilar volume with lower discounts to higher
appear in early 2023 as a result of negotiated patent Europe-like volume shares, and bigger discounts.2
litigation settlements. As they reach the market, with
eight already approved (see Exhibit 5), patients will
undoubtedly benefit from lower costs to receive the
world’s current top-selling biopharmaceutical.
Notes: Historical savings were calculated by comparing actual molecule spending to projected spending if total molecule volume had been at originator pre-
expiry prices. Projected future savings based on estimated continuing impact of biosimilar events in progress, as well as future expected expiries. The range
of savings values shown in the biosimilar savings scenarios include assumptions for high, low, and average (base case) biosimilar volume uptake and price
discounts relative to originators. Timing of expected biosimilar entry based on patent information and litigation/settlements as of Oct 2022.
Entry of new immunology biosimilars in 2023 will increase

competition in a rapidly growing market
Exhibit 23: Historic and future immunology volume in defined daily doses (DDDs) by biosimilar competition,
2013–2027
1,600 Forecast
1,400
Defined daily doses, millions
1,200
54%
1,000 54%
54%
25% 54%
25% 55%
800
26%
28%
600 31%
33% 58% 29%
59% 29% 29%
400 56% 28%
54% 28%
87% 85% 52%
91% 91% 51%
200
17% 17% 17% 17% 17%
18% 18% 18% 16% 17%
9% 9% 13% 15% 16%
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
Small molecule Biologics without biosimilars Biologics with biosimilars
Source: IQVIA MIDAS, Jun 2022; IQVIA Institute, Dec 2022.
• The immunology market has been one of the fastest • These biosimilar launches will increase the share of
growing therapy areas in the U.S. at 13% annual net total immunology volume accessible to biosimilars,
spending growth from 2017 to 2021. 7
from 25% in 2022 to 55% in 2023, and two-thirds of
biologic volume in the immunology market will face
• Immunology volume measured in defined daily doses
biosimilar competition.
has grown an average of 11% annually over the last
five years and is forecasted to continue to grow 8% • With no additional immunology drugs expected to face
annually through 2027. biosimilar competition in the forecast period, the share
of the market accessible to biosimilars is expected
• Biosimilars are expected to launch starting in 2023 for
to remain relatively consistent from 2023 to 2027, as
blockbuster immunology drugs adalimumab (Humira),
incremental volume from biosimilars and launch of
ustekinumab (Stelara), and tocilizumab (Actemra) as all
innovative biologics continue to increase the utilization
three lose patent protection and biosimilars have been
of immunology drugs.
approved or are in late-stage development.
Notes: Historical values are from IQVIA audits, and values for 2023–2027 are based on modeling of immunology volume based on current growth trends and
expected future market events. Timing of expected biosimilar entry based on patent information and litigation/settlements as of Oct 2022.

Product characteristics and reimbursement decisions are likely to

impact adalimumab biosimilar uptake beginning in 2023
Exhibit 24: Timeline of adalimumab biosimilar entry and lessons from Europe
Wave of biosimilar launches Share of adalimumab volume in EU4+UK by product

• 6 low conc.: 5 are citrate-free; characteristic, Q1 2015-Q3 2022
100%
1 (possibly 2) interchangeable at launch
90%
• 1 high conc., citrate-free
80%
• 2 additional high conc. submitted to
FDA, one with interchangeability 70%
60%
January September–
50%
40%
July 30%
20%
First biosimilar launch Later biosimilars and
interchangeability 10%
• Low conc., citrate-free
• 1 additional low conc. launch 0%
• High conc., interchangeability
Se 5
M 5
-16
M 6
-17
M 7
-18
M 8
-19
M 9
-20
M 0
-21
M 1
-22
22
trial completed in Dec 2022 • Previous launched
-1
1
2
p-
p-
p-
p-
p-
p-
p-
p-
ar
ar
ar
ar
ar
ar
ar
ar
Se
Se
Se
Se
Se
Se
Se
M
biosimilars could achieve
interchangeability Humira low conc. with citrate Biosimilar low conc. with citrate
Humira high conc., citrate-free Biosimilar low conc., citrate-free
Biosimilar high conc., citrate-free
• The launch of adalimumab biosimilars in 2023 will be differences are variations in concentration and
one of the most significant biosimilar events in the presence or absence of citrate.
U.S. market and is expected to dramatically impact
• In major European markets prior to biosimilar entry,
spending on biologics.
nearly all of adalimumab volume had shifted to high
• Adalimumab (Humira) contributes nearly $28Bn concentration, citrate-free Humira, noted as reducing
annually to spending at invoice levels in the U.S. and injection site effects for patients. Similar patterns have
has had over $165Bn in lifetime sales, making it the been seen in the U.S. (not shown).
best-selling biopharmaceutical (see Exhibit 6).
• Following biosimilar launch in the EU4+UK beginning in
• Eight biosimilars have been approved by the FDA 2018, concentration and presence or absence of citrate
referencing adalimumab with the first expected to has appeared to have little impact on biosimilar uptake
launch on January 31, 2023. A wave of additional
8
as low concentration biosimilars with citrate have had
biosimilars are currently expected to launch in July significant adoption, accounting for 39% of volume and
2023, with more following through the end of the year. low concentration, and with citrate-free biosimilars
accounting for 29% of volume. Originator volume has
• At the time of launch these biosimilars will have
dropped to 30%.
differences in formulation and interchangeability that
could impact uptake. The most important formulation
Notes: Conc.=concentration. Biosimilar launch timelines and product characteristics based on publicly reported company statements, FDA labels, and EMA
European public assessment reports (EPARs). Volume shares in EU4+UK (France, Germany, Italy, Spain, UK) based on defined daily doses (DDDs).
Biosimilars will continue to impact all aspects of the healthcare

system, with significant implications from upcoming events
Exhibit 25: Key biosimilar implications for stakeholders across the healthcare system
Patients Providers
Insurance coverage and Patient stability and compliance with

out-of-pocket costs current therapy
Treatment experience with existing Likelihood of payer coverage for
therapies patient population
Recommendations from provider Incentives for biosimilar prescribing
Payers Biosimilar companies
Reimbursement decisions and Assessing viable opportunities for

formulary placement of biosimilars biosimilar development (i.e., ROI)
will impact uptake
Cost vs. benefit of interchangeability
Interchangeability a relatively new
aspect
Source: US Market Access Strategy Consulting, IQVIA Institute, Dec 2022.
• Biosimilars represent significant opportunity for • Payers will continue to impact the degree to
reducing costs and increasing access to medicines in which patients have access to biosimilars through
the U.S. healthcare system. With biosimilars seeing reimbursement decisions and formulary placement,
increasing acceptance in the U.S. and the scale of which are influenced by rebates and design of
spending on medicines facing upcoming biosimilar coverage plans. As interchangeability becomes more
competition increasing, the impact on all stakeholders common for pharmacy-dispensed drugs, payers will
will be significant. need to determine how this impacts coverage.
• When choosing to use a biosimilar product, patients • Biosimilar companies must evaluate the opportunities
will be primarily influenced by the coverage of the available for biosimilar development and how future
biosimilar through insurance and any out-of-pocket market dynamics, including the recently passed
costs the patient may be responsible for. Provider Inflation Reduction Act (IRA), will impact the potential
recommendations also impact patient views on return on investment.
biosimilars.
• As shown throughout this study, providers have

significant influence on the utilization of biosimilars,
with patient experience with current therapies,
reimbursement decisions, and incentives driving
provider decision-making.

Notes on sources
THIS REPORT IS BASED ON THE IQVIA SERVICES DETAILED BELOW
IQVIA LONGITUDINAL PRESCRIPTION DATA IQVIA™ PIPELINE INTELLIGENCE is a drug pipeline

IQVIA receives nearly 4 billion prescription claims per database containing up-to-date R&D information
year with history from January 2006 with coverage over on over 40,000 drugs, and over 9,000 in active
90% for the retail channel, 60–85% for mail service, and development worldwide. The database captures the
75– 80% for long-term care. Longitudinal data derives full process of R&D, covering activity from discovery
from electronic data received from pharmacies, payers, stage through preclinical and clinical development, to
software providers and transactional clearinghouses. approval and launch.
This information represents activities that take place
NATIONAL SALES PERSPECTIVES® (NSP) measures
during the prescription transaction and contains
revenue within the U.S. pharmaceutical market by
information regarding the product, provider, payer, and
pharmacies, clinics, hospitals and other healthcare
geography. Rx data is longitudinally linked back to an
providers. NSP reports 100% coverage of the retail and
anonymous patient token and is linkable to events within
non-retail channels for national pharmaceutical sales
the data set itself and across other patient data assets.
at actual transaction prices. The prices do not reflect
IQVIA MIDAS is a unique platform for assessing
®
off-invoice price concessions that reduce the net amount
worldwide healthcare markets. It integrates IQVIA’s received by manufacturers.
national audits into a globally consistent view of the
pharmaceutical market, tracking virtually every product
in hundreds of therapeutic classes, and provides
estimated product volumes, trends and market share
through retail and non-retail channels. MIDAS data is
updated monthly and retains 12 years of history.
IQVIA DRUG DISTRIBUTION DATA (DDD) or Sub-

National Outlet-Level Sales, combines direct shipments
from manufacturers and wholesalers to retail and non-
retail purchasers, to provide outlet-level data. Data are
provided by participating companies and wholesalers
and pooled and blinded to limit contributors to viewing
granular data for their own products and summarized
results for others. Outlet level analysis in this report is
further blinded to mask the specific outlets and products
consistent with IQVIA contractual obligations with
data providers.
Definitions and methodology
BIOLOGIC: IQVIA defines biologic medicines as DEFINED DAILY DOSE (DDD): The World Health
complex macromolecules such as proteins, nucleic acids Organization (WHO) has developed a method of
and carbohydrates. They must be clearly identified normalizing medicines of varying intended doses
with specific molecule name(s) and exclude more using a defined daily dose (WHO-DDD). The WHO-DDD
general descriptions such as ‘vegetable extract’. Fixed measure is intended to represent a standard day of
combinations of biologic and small molecule products therapy for a maintenance dose of a chronic therapy. The
are considered biologic. WHO-DDD measure does not reflect actual treatment
decisions and is not derived from distinct patients
BIOSIMILAR: a non-original biologic medicine produced
measured with anonymized data. The IQVIA Institute
through recombinant technology and approved
has followed the same concepts and guiding principles
through an abbreviated pathway. In the United States
in developing DDDs for additional medicines, ultimately
the Biologics Price Competition and Innovation Act
extending the medicines with defined dosing to cover
(BPCIA) created the 351(k) pathway for biosimilars,
over 90% of chronic medicine volume and over 75% of all
however some products were approved through
medicine volume. Note: this is unrelated to IQVIA’s Drug
the 505(b)(2) pathway for abbreviated approvals of
Distribution Data offering, also named DDD.
nonoriginal products referencing another product in the
submission. Others were submitted as a BLA or original AVERAGE SALES PRICE (ASP): Manufacturers average
biologics license application under the 351(a) pathway. sales price to all purchasers excluding Medicaid and
Biosimilars in this report include non-original biologics certain federal discounts or rebates. ASP does not
submitted through any of these pathways. FDA approved reflect separately negotiated discounts and rebates with
enoxaparin sodium via the standard generic pathway as insurers or pharmacy benefit managers.
an ANDA and also does not consider it a biosimilar.
BIOSIMILAR SAVINGS: the amount of spending lower
HERFINDAHL-HIRSCHMAN INDEX: The Herfindahl than what would have been spent if all volume had been
index is a measure of the size of firms in relation to the at originator pre-biosimilar prices.
industry and an indicator of the amount of competition
among them. Named after economists Orris C.
Herfindahl and Albert O. Hirschman, it is an economic
concept widely applied in competition law, antitrust and
also technology management. It is calculated as the
sum of the squares of the market share of each market
participant, with monopoly situations resulting in an
index of 1.0 and multiple evenly distributed competitors
approaching but never reaching zero.

References
1. IQVIA Institute for Human Data Science. The prospects for biosimilars of orphan drugs in Europe: current
landscapes and challenges ahead. Jul 2020.
2. Troein P, Newton M, Stoddart K, Arias A. The impact of biosimilar competition in Europe. IQVIA. Dec 2019.
3. Fein AJ. White bagging update 2022: hospitals battle to boost buy-and-bill. Drug Channels Institute. Sep
2022. Available from: https://www.drugchannels.net/2022/09/white-bagging-update-2022-hospitals.html.
4. IQVIA Institute for Human Data Science. Shared savings programs in Europe: lessons for the United States.
Dec 2022.
5. Abt Associates. Evaluation of the Oncology Care Model: participants’ perspectives. Dec 2021. Available from:
https://innovation.cms.gov/data-and-reports/2021/ocm-ar4-eval-part-persp-report.
6. Foster E, Niyogi S, Adolph N, Savage E. Lessons from Semglee: early perspectives on pharmacy biosimilars.
IQVIA. Nov 2022.
7. IQVIA Institute for Human Data Science. The use of medicines in the U.S. 2022: usage and spending trends
and outlook to 2026. Apr 2022.
8. Amgen. Amgen and AbbVie agree to settlement allowing commercialization of AMGEVITA™. Sep 2017.
Available from: https://www.amgen.com/newsroom/press-releases/2017/09/amgen-and-abbvie-agree-to-
settlement-allowing-commercialization-of-amgevita.
About the authors
MURRAY AITKEN MICHAEL KLEINROCK
Executive Director, IQVIA Institute Research Director, IQVIA Institute
for Human Data Science for Human Data Science
Murray Aitken is Executive Director, IQVIA Institute Michael Kleinrock serves as Research Director for
for Human Data Science, which provides policy setters the IQVIA Institute for Human Data Science, setting
and decisionmakers in the global health sector with the research agenda for the Institute, leading the
objective insights into healthcare dynamics. He led development of reports and projects focused on the
the IMS Institute for Healthcare Informatics, now the current and future role of human data science in
IQVIA Institute, since its inception in January 2011. healthcare in the United States and globally. Kleinrock
Murray previously was Senior Vice President, Healthcare leads the research development included in Institute
Insight, leading IMS Health’s thought leadership reports published throughout the year. The research is
initiatives worldwide. Before that, he served as Senior focused on advancing the understanding of healthcare
Vice President, Corporate Strategy, from 2004 to 2007. and the complex systems and markets around the world
Murray joined IMS Health in 2001 with responsibility that deliver it. Throughout his tenure at IMS Health,
for developing the company’s consulting and services which began in 1999, he has held roles in customer
businesses. Prior to IMS Health, Murray had a 14-year service, marketing, product management, and in 2006
career with McKinsey & Company, where he was a leader joined the Market Insights team, which is now the IQVIA
in the Pharmaceutical and Medical Products practice Institute for Human Data Science. He holds a B.A. degree
from 1997 to 2001. Murray writes and speaks regularly in History and Political Science from the University of
on the challenges facing the healthcare industry. He is Essex, Colchester, UK, and an M.A. in Journalism and
editor of Health IQ, a publication focused on the value Radio Production from Goldsmiths College, University of
of information in advancing evidence-based healthcare, London, UK.
and also serves on the editorial advisory board of
Pharmaceutical Executive. Murray holds a Master of
Commerce degree from the University of Auckland
in New Zealand, and received an M.B.A. degree with
distinction from Harvard University.

About the authors
JAMIE PRITCHETT
Thought Leadership Manager,
IQVIA Institute for
Human Data Science
Jamie Pritchett is Thought Leadership Manager for the

IQVIA Institute, managing aspects of IQVIA Institute
projects and conducting research and analysis within
global healthcare. Prior to joining IQVIA in 2021, he held
positions with the North Carolina Department of Health
and Human Services and the Duke Human Vaccine
Institute, where he developed skills in understanding
and addressing the array of physical, environmental, and
social contributors to individual health. Jamie uses his
experience in public health, health communication, and
drug development and research to understand current
trends in healthcare and the life sciences industry.
He holds a Bachelor of Science in Animal Science and
Zoology and a Master of Toxicology from North Carolina
State University.
About the Institute
The IQVIA Institute for Human Data Science • Understanding the future role for biopharmaceuticals
contributes to the advancement of human health in human health, market dynamics, and implications
globally through timely research, insightful analysis and for manufacturers, public and private payers,
scientific expertise applied to granular non-identified providers, patients, pharmacists and distributors.
patient-level data.
• Researching the role of technology in health system
Fulfilling an essential need within healthcare, the products, processes and delivery systems and the
Institute delivers objective, relevant insights and business and policy systems that drive innovation.
research that accelerate understanding and innovation
Guiding principles
critical to sound decision making and improved
The Institute operates from a set of guiding principles:
human outcomes. With access to IQVIA’s institutional
knowledge, advanced analytics, technology and • Healthcare solutions of the future require fact based
unparalleled data the Institute works in tandem with a scientific evidence, expert analysis of information,
broad set of healthcare stakeholders to drive a research technology, ingenuity and a focus on individuals.
agenda focused on Human Data Science including
• Rigorous analysis must be applied to vast amounts of
government agencies, academic institutions, the life
timely, high quality and relevant data to provide value
sciences industry, and payers.
and move healthcare forward.
Research agenda
• Collaboration across all stakeholders in the
The research agenda for the Institute centers on
public and private sectors is critical to advancing
five areas considered vital to contributing to the
healthcare solutions.
advancement of human health globally:
• Insights gained from information and analysis should
• Improving decision-making across health systems
be made widely available to healthcare stakeholders.
through the effective use of advanced analytics and
methodologies applied to timely, relevant data. • Protecting individual privacy is essential, so research will
be based on the use of non-identified patient information
• Addressing opportunities to improve clinical
and provider information will be aggregated.
development productivity focused on innovative
treatments that advance healthcare globally. • Information will be used responsibly to advance
research, inform discourse, achieve better healthcare
• Optimizing the performance of health systems by
and improve the health of all people.
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.

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.
This algorithmic art is based on the sales, volume, and

cost per day of therapy for biosimilar and originator
products in the United States from 2010-2022.
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Iqvia Institute Biosimilars in The United States 2023 Usl Orb3393

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Iqvia Institute Biosimilars in The United States 2023 Usl Orb3393

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Biosimilars in the

Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

Market dynamics and biosimilar development 4

Factors influencing biosimilar uptake 13

Biosimilar impacts on molecule volume and price 20

Future impacts of biosimilars 26

Definitions and methodology 34

About the authors 36

About the Institute 38

2 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

4 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

The U.S. biologics market continues to grow faster than

Year-over-year spending growth Leading drug classes

Source: IQVIA MIDAS, Dec 2021; IQVIA Institute, Nov 2022.

Molecules with biosimilars total $38Bn of invoice spending, while

Molecules with potential

Molecules without biosimilars

6 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

Most of the molecules with biosimilars in development continue to

Originator protected 21 molecules

Originator protected 145 molecules

Biosimilars launched to date account for 24% of competitive

Source: IQVIA MIDAS, Sep 2022; IQVIA Institute, Dec 2022.

8 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

Since 2007, 30 biosimilars have launched in the U.S. with 10 more

Exhibit 5: Biosimilars approved and launched in the U.S.

Source: IQVIA Institute, Dec 2022.

There are biosimilars approved or in clinical development in the

10 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

For molecules facing biosimilars, competitiveness is highly varied

Exhibit 7: Market concentration Herfindahl-Hirschman Index and shares by competitor Q3 2022

ranibizumab teriparatide epoetin alfa pegfilgrastim filgrastim rituximab

Source: IQVIA MIDAS, Sep 2022; IQVIA Institute, Dec 2022.

Development of biosimilars is being driven by smaller companies,

Biosimilars in development Marketed biosimilars by company type and size

Large pharma Other

• There are six biosimilar products that were developed

12 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

• Biosimilar products were more readily adopted among

Molecules with biosimilars first launched in 2019 have seen significant

Recent biosimilars have achieved high volume shares, reaching

Exhibit 9: Biosimilar share of volume since biosimilar launch

14 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

Most providers are using a biosimilar of bevacizumab more than

Exhibit 10: Use of biosimilars and originator bevacizumab within outlets

Originator and biosimilars share of Top 100 highest-volume outlets

to outlets 2020 vs. 2022

Biosimilar share of outlet

Higher volume Lower volume

Outlet volume rank 1-100

Lower share Higher share

Source: IQVIA DDD, Oct 2022; IQVIA Institute, Dec 2022.

Biosimilars have had stronger uptake in buy-and-bill, where

90% White-bagged 90% Buy-and-bill

16 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability

Biosimilar products were more readily adopted among professional

100% Institutional 100% Professional

• In professional settings, biosimilars have had a

• Although eventually reaching similar levels of uptake in

Providers participating in the Oncology Care Model adopted

100% OCM participant 100% Other

80% 77% 76% 80%

18 | Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability