The Need for Safe and Affordable Biopharmaceuticals Drives the Development of the European Biosimilars Market, Says Frost & Sullivan

LONDON - Despite the initial regulatory hiccups, the number of biosimilars in the
European market is set to increase gradually. The patent expiry of key
biopharmaceuticals has opened up numerous lucrative market opportunities,
while driving the development of biosimilars. In addition, payers’ perception
of biosimilars, as viable alternatives to originator drugs due to their
safety, efficacy and affordability, will further bolster market prospects.

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“Patent expiries of some top selling biopharmaceuticals have resulted in
a massive market opportunity for biosimilar manufacturers,” notes Frost &
Sullivan Senior Research Analyst Sumanth Kambhammettu. “Product classes such
as erythropoietins, insulin and analogs, granulocyte colony-stimulating
factors, human growth hormones and interferons, which have all lost patent
protection, had a collective market size of approximately US$34.04 billion in
2007.”

If you are interested in a virtual brochure for the latest analysis from
Frost & Sullivan (www.pharma.frost.com) titled, European Biosimilars
Market Outlook, which provides manufacturers, end users and other industry
participants with an overview of the study, send an e-mail to Katja Feick,
Corporate Communications, at katja.feick@frost.com. Please include your full
name, company name, title, telephone number, company e-mail address, company
website, city, state and country. Upon receipt of the above information, an
overview will be sent to you by e-mail.

Expensive biopharmaceuticals are used primarily for critical diseases
like cancer and diabetes, whose incidence is increasing due to Europe’s
ageing population. Subsequently, the patent expiries of key product classes
and an increasing emphasis on cost containment are motivating governments to
switch to affordable alternatives. Thus, there exists tremendous growth
opportunity for biosimilar manufacturers.

However, the development of biosimilars is riddled with complexities,
ranging from R&D and manufacturing to marketing. Their development remains
one of the most expensive propositions in the pharmaceutical industry. In
addition, meeting the stringent regulatory norms set by the European
Medicines Agency (EMEA) will be an arduous exercise.

The current average cost of bringing a biosimilar to market is around
US$100-US$200 million, in addition to a development period ranging from eight
to ten years. This is approximately equivalent to the same for a
biopharmaceutical product. Marketing presents another key challenge as,
typically, there is initial resistance from the physician community.

“The most significant challenge, however, will be in proving similarity
with the reference product as per the EMEA standards,” adds Kambhammettu.
“This is because the entire process involves large-scale clinical trials as
well as the documentation and submission of immense volumes of data.”

Pricing will be a key factor to recover the high level of investment that
is required to develop and manufacture biosimilars. In addition, marketing
strategies will have to be very different from generic drugs.

“While pricing a biosimilar, manufacturers must assess various factors
such as the nature of the market, product class, level of competition and
reimbursement structure,” advises Kambhammettu. “As current biosimilars are
marketed in the hospital sector, manufacturers must focus their marketing
efforts on specialists to increase the probability of success. Moreover, they
must make efforts towards advancing physician awareness by disseminating data
pertaining to long-term safety and efficacy of biosimilars.”

European Biosimilars Market Outlook is part of the Pharmaceuticals &
Biotechnology Growth Partnership Services programme, which also includes
research in the following markets: Drug Approval Process in Europe,
Opportunities in the CRO Market - Phase 0, European Vaccines Market, European
Biosimilars Market, European Human Growth Hormones Market, European
Therapeutic Monoclonal Antibody Market, European Drug Delivery Market, and
European Lung Cancer Therapeutics Market. All research included in
subscriptions provide detailed market opportunities and industry trends that
have been evaluated following extensive interviews with market participants.
Interviews with the press are available.

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European Biosimilars Market Outlook
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Contact:
Katja Feick
Corporate Communications
P: +49-(0)-69-7703343
E: katja.feick@frost.com

www.frost.com/

Source: Frost & Sullivan

Katja Feick, Corporate Communications of Frost & Sullivan, +49-(0)-69-7703343, katja.feick at frost.com ; Photo: https://www.newscom.com/cgi-bin/prnh/20081117/FSLOGO