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The history of biosimilars
Although biosimilars have been available on the
European market for the last ten years, adoption
in Latin America, Asia and the US has only
been a very recent thing. As a result of these
developments and growing acceptance of the
practice, the global market is due to grow at a
compound annual growth rate (CAGR)of 49.1%
between 2015 and 2020, according to an Allied
Market Research report.
The global biosimilars market
is due to grow at a CAGR of
49.1% between 2015 and 2020
- Allied Market Research
McKinsey Company’s recent insight document
revealed that RD investments for biosimilars
are at an all-time high. Despite this, revenues
generated from biosimilars have been fairly poor
thus far with cumulative sales only having reached
$1.2 billion since 2006. However, it is predicted
that the market has the potential to be worth
$20 billion by 2020.
Why are firms interested in
developing biosimilars?
Biosimilars are lauded for their ability to provide
affordable access to important drug-based
therapeutic treatments to patients who require
them.This is then coupled with savings due to a
reduction in RD costs. Leading market experts
claim that biosimilars could provide up to $250
billion in savings to the US Healthcare system
over the next decade, according to a McKinsey
Company report.
Biosimilars are lauded for their
ability to provide affordable,
heavily discounted drugs due to
reduced RD costs
What has triggered these recent
changes?
Historically, Europe has been the dominant force
in the biosimilars market,but with the introduction
of the Affordable Care Act by President Obama in
2010 coupled with the fact that by 2016, biologic
products with aggregate sales of c$60 billion are
expected to be off-patent in the US, the US has
a clear pathway for biosimilars that is only going
to grow.This was confirmed as the US secured a
first biosimilar entry product through Novartis/
Sandoz’s Zarxio breakthrough in September 2015
The US secured a first biosimilar
entry product in September
2015
Novartis/Sandoz is offering Zarxio at a 15%
discount to the original drug produced by
Amgen Inc., known as Neupogen. The threat of
such practices could result in a loss of $50 billion
in annual sales of drugs made by competitor
BIOSIMILARS: ABOUT TO CHANGE THE US
PHARMA INDUSTRY FOR GOOD?
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companies, a Bloomberg report states. In eastern
European and Scandinavian markets, where
certain biosimilar drugs have been available for
some time, discounts range from 30% to 72%.
Commenting on such practices,Laurent Chanroux,
the associate director at Research Partnership,
said: “In some of the eastern European and
Scandinavian markets in which these drugs have
been launched for some time we have seen
uptake primarily driven by the discounts offered.”
As such the US can learn a lot from the European
biosimilars market. In the EU5 countries (France,
Germany, Italy, Spain and the UK) biosimilar
penetration is between 30%-40%; in the UK, 70%
of available filgrastim – the basis for Zarxio – is
biosimilar. With uncertainty surrounding how the
market will evolve, it is essential that the US and
other countries looking to expand their biosimilar
offerings analyse the data available from regions and
businesses with a history of biosimilar experience.
The US should analyse data
from regions with previous
biosimilar expertise
As well as looking at pricing structures and
potential savings, understanding and remaining
aware of the regulatory changes that are coming
into effect must be a priority.The FDA is hoping
to pass more regulatory changes to encourage
further expansion of the biosimilars market, and
has released a number of QA documents on
the subject in the last few weeks.
Investments are reflecting this expansion, with an
estimated 25% of biologics sales relating to off-
patent products being made in 2020. However,
in order to execute an effective biosimilar market
plan companies will need to utilise the skills of
biologics innovators and seek partnerships with
biosimilar sponsors.
Companies will need to hire
biologics innovators and partner
with biosimilar sponsors to
execute effective biosimilar
market plans
Leading pharmaceutical companies have paired
up to better explore the opportunities offered
by biosimilar products. Amgen and Actavis have
joined to run biosimilar projects,and Baxter,Merck
and Biogen have all struck similar deals.Due to the
infancy of the industry, however, some companies
have had to dissolve new partnerships (Pfizer
and Biocon are a prime example) as the journey
to biosimilar success is as yet unmapped. Intense
development investment, significant clinical work
and high costs can make the process difficult.
How can you take advantage of
these changes?
Whether businesses or candidates decide to
investigate biosimilars further, two things are
certain: biosimilars are coming to the US and
biopharmaceutical companies will need to evolve
their commercial strategies to address them.
Candidates who enter
biosimilars early will surely
benefit from the inevitable
growth of the sector
Those who invest in biosimilars early will surely
benefit from the inevitable growth of the sector.
From a candidate standpoint, entering the
biosimilars market at the present time will mean
gaining a foothold and experience in a soon-to-
be hugely significant sector, as well as exposure to
drug development with a focus on patient benefit.
In any new market, those that get in early are the
ones who enjoy the benefits of the growth that
follows – a rising tide lifts all boats. Candidates
getting into the biosimilars industry early, are
provided with a fantastic chance to expedite their
career path as a result. With biosimilars being a
new market, employers have to show a degree
of flexibility from a skill-set perspective with who
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they bring into new roles.That said, as the market
develops, this will change.
With biosimilars being a new
market, employers need to be
flexible
In Europe where the biosimilars market has
been buoyant for several years now, the demand
by employers for candidates with biosimilars
experience is increasing, thus raising the barriers
to entry to become part of this area of the
market. Some people will say that biosimilars
are less scientifically interesting than novel drug
development, and therefore the work is not
‘exciting’, however these people tend to ignore
the bigger picture and the scale of the benefits for
the payer and the patients.
People are naturally motivated by different things,
but if you are looking to develop your skill set
and find a way to drive your career progression
forward, it is definitely worth looking into the
potential of the biosimilars market now before
the window to capitalise on this growth closes.
Through EPM Scientific’s international offices
we have specialist experience working with
European biosimilar buildouts. Be it through
a biologics innovator approach, a biosimilar
sponsors approach, or a blend of the two, EPM
Scientific seeks understanding of our clients’
commercial strategy and helps them to expand
both production and sales teams in this exciting
sector.
With the imminent penetration of the biosimilars
market in the US,are you prepared and positioned
to take advantage of this significant new force, be
that via team growth or from a new opportunity
standpoint?
5. This guide has been brought to you
by EPM Scientific, part of the Phaidon
International group.
EPM Scientific is a specialist provider
of Life Sciences recruitment solutions
across Europe, the US, Asia and the
Middle East.
We believe every professional should
benefit from the advice of a trusted
partner throughout their career.
Contact EPM Scientific, for more
information about career opportunities
in this sector, or if you are looking to
expand your team.
Contact us today:
www.epmscientific.com
enquiries@epmscientific.com
Enabling Exceptional Careers
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