BIOSIMILAR INDUSTRY INTELLIGENCE :

5 KEY PERSPECTIVES

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This is the year…
Change in the biosimilars industry is really picking up pace. The regulatory

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environment is becoming ever more stable and organisations are continuing to
explore development, clinical and commercial strategies that offer genuine value to
them, healthcare providers and most importantly, the patient.

It is a busy time for the industry, but it is important to know the latest regulatory and
industry developments, realise the impact on your own operations, explore your
competitive landscape, meet potential partners and help develop a failsafe biosimilar
strategy. Take time out to do all of this in one place, the Biosimilar Drug Development
World in Madrid, March 4-5.

Get a sneak peak into some of these discussion areas issues right here, with insights
from some of the leading players of the biosimilars sector. Hear what they think, and
let them set the scene for this years BDDW conference. Find out more about the
expert panel who are speaking at this years conference at
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 Mr Alan Herman
Chief Scientific Officer
Coherus Biosciences

How do you see the biosimilars market changing over the next 5 What is the most “disruptive force” happening in the biosimilars sector?

years?
As key blocking patents begin to expire, and regulators worldwide
begin to harmonize approval pathways, we expect to see a number of
new biosimilar products coming to the market. However, due to the
very high hurdles involved in successfully developing and marketing a
biosimilar there will probably be a significant thinning and
consolidation of participating companies. The initial result will
probably be the commercialization of a handful of high value
biosimilars by a relatively small number of companies. However,
once this “low hanging fruit” has been picked, choice of additional
molecules becomes more difficult. More challenging products (from
a technical, clinical, and marketing perspective) will require higher
investments in time and money for smaller return.
What is the biggest challenge facing the biosimilars sector?
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Clearly, the most disruptive force in the biosimilars sector is the rapid
advancement of analytical and manufacturing technologies. The current state
of analytical protein chemistry, understanding of glycobiology, and advances
in in vitro functional assays are, arguably, the enabling factors in biosimilars
development. It is this high level of analytical understanding that has allowed
development of the biosimilars industry. As the analytical sciences continue
to advance, the requirements for clinical trials may decrease, thereby having
a marked affect on the cost of biosimilars development.
Related to this are the advances in commercial scale upstream and
downstream processing. These advancements have enabled the industry to
produce proteins with a very high degree of similarity to the innovator
product. Furthermore, the product can typically be made with a higher yield
(lower COG), greater purity, and enhanced consistency, relative to the
innovator product. This is true because the innovator is typically locked into
the 10-20 year old technology that was originally used to produce the drug.

There are a huge number of challenges facing the biosimilar sector: This combination of analytical and manufacturing technologies has resulted in
patent protection, an uncertain regulatory environment, competition the potential to quickly develop biosimilar product of the highest quality.
with both the innovator and other biosimilar companies, among
others. However, choosing the right molecule to pursue probably
remains the most difficult of these challenges. Multiple factors,
including market opportunity, patent and IP analysis, technical
difficulty, and complexity of clinical trials must be considered.
Beyond that, interactions with payers and providers, the decision to
partner or not, as well as consideration of market entry timing must
be examined. The relationship between all of these factors is
complex and a product with high potential sales may be prohibitively
difficult to produce. Alternatively, a molecule that is relatively easy to
make may require a series of lengthy clinical trials. It is critical that
the appropriate balance of these many factors be met. 3
 Dr Steinar Madsen
Medical Director
Norwegian Medicines Agency

Where do you see the greatest opportunity for growth in the
biosimilars market?
I think we will see worldwide growth in the biosimilar market. US is
of course the biggest single market and penetration of this market
is obviously very important. With FDA now signalling a positive
attitude towards approval of biosimilar filgrastim, the race is on. A
lot will also depend on the success of biosimilar infliximab in Europe
in 2015. Success here may pave the way for success in the US.
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What is the most “disruptive force” happening in the biosimilars sector?
(this could be a person, company, regulation, new technology, new
partnership – something or someone who is taking a revolutionary
approach to biosimilar development and launch)
The possibly most disruptive force will be originator industry if they really
fights back by slashing prices in an attempt to terminate the biosimilar
adventure. It is not very likely, but it would be a spectacular event.

What role do partnerships play in your biosimilar strategy? How do you

ensure the success of a partnership?
How do you see the biosimilars market changing over the next 5
years? The most important partnership is with the patients that have only one
wish, to get treatment. The winner will be the one that has the most to
In the next 5 years we will probably have biosimilars of all the offer to the patients.
present “great fishes” – including infliximab, rituximab, etanercept
and adalimumab. With competitive prices, it will have a significant
impact on drugs costs worldwide that will benefit a large number of
patients. It is very important to keep the biosimilar alternative alive,
and I guess we will see a lot of manoeuvrings from biosimilar
companies, originator companies, physicians, patiens and payers.

What is the biggest challenge facing the biosimilars sector?

A clinical disaster, like the epoetin/Eprex affair, that would
undermine confidentiality in biosimilars in general and rise new
commercial and regulatory hurdles.

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 Mr Cyrus Karkaria,
President Biotech
Lupin Pharmaceuticals

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Where do you see the greatest opportunity for growth in the
biosimilars market?

The greatest opportunity for growth in the biosimilars market is in big

emerging markets where there is better acceptance.

How do you see the biosimilars market changing over the next 5
years?

I see the market changing gradually at first and then more rapidly,
again because of better acceptance and awareness regarding efficacy
and quality.

What is the biggest challenge facing the biosimilars sector?

The biggest challenge will be convincing physicians to prescribe, and

payers to accept them as equivalent.

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 Francisco Rebollo Laserna
Medical Manager Biosimilars,
Sandoz Farmaceutica Sa

Where do you see the greatest opportunity for growth in the
biosimilars market?
There are currently a great development of the new monoclonal
antibodies (MAbs) biosimilars. Now there´s one which is at the
present time approval at EMA and in the next years a full battery
of new MAbs biosimilars will arrive for the armamentarium of
physicians and will allow them to use more affordable
treatments. This MAbs are mainly focused in anti-inflammatory
areas and also in the oncology areas.
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What is the biggest challenge facing the biosimilars sector?
As biosimilars are a more complex molecules they
have stringent requirements but in a different frame as a new
molecule. The perception that we are now facing in a different
environment and understand it maybe it is a clear challenge for
biosimilars.

How do you see the biosimilars market changing over the next 5
years?

The market will be have a dramatically change, up to now the

majority of biosimilars, GCSFs and EPOs are basically supporting
treatment. In the next year we will see a new wave of biosimilar
drugs that are focused in the treatment of diseases and that´s
going to give a need to adapt the behaviours of actuation, not
only physicians but rest of the actors as vendors, Health
Authorities…

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 Dr Malcolm Mitchell,
Senior Medical Fellow
Eli Lilly and Co

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How do you see the biosimilars market changing over the next 5 What is the biggest challenge facing the biosimilars sector?
years?
So the biggest hurdle to the growth of the biosimilar is ignorance and
Since my qualification in the early 70s I had always been the means of dealing with this is key to the success or failure of the
encouraged to prescribe generically, it is likely at least as far as market, and if badly handled then the future of the whole biosimilar
payers are concerned the biosimilars offer a new type of “generic”. industry could be damaged. Bad news sells paper and grows media
It is the medical and general community that need to accept this angst.
principle against at least a European context that genetically
modified food is something to be cautious of accepting into the
greater food chain. Most people accept medicines which are
“bioengineered” but will the arrival of biosimilar remind the
general public that biological medicinal agents are also
bioengineered.

What is the most “disruptive force” happening in the biosimilars

sector?

The inate conservatism of the medical community must also be

taken into account, the prescribe what I know culture dominates.
So what needs to be overcome maybe the name biosimilar
because what we are really seeing are agents that cannot be
differentiated from the originator. To many of us that means you
are unable to tell the copy or pirated version of the originator, so if
you can’t determine which is the designer watch from the copy
then the obvious reaction is you’re stupid. This must not happen
with biosimilars where the quality of both is assured. Regulators
must be able to convince the public that the biosimilar has the
same high standard as the original.

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 Want to learn more?

These key players will be speaking at the Biosimilar

Drug Development World Europe event, happening this
4-5 March in Madrid.

Navigate the challenges in the clinic, the manufacture

and development of biosimilar medicines as well
as explore the commercial aspects of the industry.

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