martes, 13 de septiembre de 2011

Biosimilar o..."biobetter"? / Similar o superior...?

In the last 10 years a good deal of attention has been paid to the emerging market for biosimilar drugs* or, in other words, copycat versions of biologic brands. However, questions have been raised about the economics of the approach.

"On the face of it, the economics for biosimilars remain compelling. Worldwide, biologic drugs generate more than $120bn in sales and recent market research from Datamonitor indicates that more than 30 branded biologics worth a huge $51bn will lose patent exclusivity in the next five years. The global biosimilar market is expected to grow dramatically, from $243m in 2010 to $3.7bn by 2015."


"For some, the biosimilar figures do not add up. The high cost of development, manufacturing and marketing means that margins may be tight and preclude sufficient price discounting to encourage substitution of a well-established brand. There is some evidence for that view. The first US-approved biosimilar, Sandoz' human growth hormone Omnitrope, has 'low single-digit' market share, according to the company, and a few million dollars in annual sales, despite being on the market since 2006."


"Given that biobetter development is akin to the traditional line-extension model in pharma, it is no surprise that many of the players are companies with established biologic brands, such as Roche, Biogen Idec and Amgen.

Novo Nordisk and Merck & Co are notable in that they have made biobetters an intrinsic part of the product development strategy, while AstraZeneca division MedImmune recently rewrote its strategy to focus almost exclusively on developing biobetter versions of antibody-based drugs.

A new class of biobetter company is also emerging. These tend to be smaller, sometimes virtual firms that outsource development and manufacturing tasks in order to reduce costs, cut the time to market and increase the return on investment."



Buckets Of Money: Biosimilars & Billions Of Dollars

Biosimilares en PHARMACOSERÍAS

(*) Ver /Fernando de Mora UAB

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