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European biosimilar market will be worth $4bn a year by 2017

Industry should take advantage of patent expirations of major branded biologics say Frost & Sullivan

The biosimilar industry in Europe is set to reach annual revenues of $4bn by 2017 as major branded drugs face patent expiration, according to a new study.

Analysts Frost & Sullivan say the market, which was worth around $172m in 2010, will achieve a compound growth rate of 56.7 per cent from 2010 to 2017, boosted by sales from emerging biosimilar versions of monoclonal antibody, insulin and interferon products.

Behind this growth will be the potential better value of biosimilar products, once patent expiries of branded products allows them to reach the market.

Research Analyst Srinivas Sashidhar said: "Price reduction strategies will ensure increased adoption among physicians and patients alike, spurring market advancement."

Plans from the European Medicines Agency (EMA) to update guidance on biosimilars should also be beneficial to the industry, with the regulator due to clarify the definition of a biosimilar product and how it differs from a generic drug.

The US Food and Drug Administration has also recently announced moves to develop a biosmiilar pathway, offering guidance on how to bring equivalent versions of off-patent biologic drugs to market. No biosimilar products are currently available in the US.

However, the Frost and Sullivan report did identify several issues the biosimilar industry will face over the coming years, with high manufacturing costs and the need for a sizeable investment in developing biosimilars hindering smaller firms' entrance into the market.

Licensing agreements between companies were suggested as a way to overcome such issues for smaller companies.

Firms to make recent moves in biosimilar advancement include Novartis' generics business Sandoz and generics firm Hospira, both of which have biosimilar versions of Amgen products in development.

Amgen itself announced a deal in December, 2011, to work with Watson Pharmaceuticals to jointly develop and commercialise several cancer biosimilars.

As well as greater efforts into development and manufacturing though, Frost & Sullivan also said biosmilar uptake needs effective sales communication to the scientific community, as well as "close and constant" interaction with doctors and pharmacists.

For some, such as director general of the European Generic medicines Association, Greg Perry, it isn't just companies that need to increase efforts, and more can be done at a policy level to develop the European biosimilars market too.

In an interview with PMLiVE, he said: "The South Koreans have launched an industrial policy for biosimilars with the aim of getting 25 per cent to the market; the Indian government has set up a priority taskforce to make its pharma industry the number one in generics, biosimilars and innovations. I think Europe is lagging behind."

15th February 2012

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