Tuesday, September 27, 2011

Woodcock reports release of biosimilars is imminent

While the release of guidance for biosimilars have been long awaited by the Pharmaceutical industry, Janet Woodcock has stated it could come as early as next week, but definitely before the end of the year.  Reuters reports that Pharma representatives and the FDA have come to an agreement on how fees would be collected to support the biosimilars process and a pathway.  While biosimilars are a generic version of biologics, which are used to treat such diseases as diabetes and multiple sclerosis.

What do you anticipate to see from the long-awaited biosimilars draft guidance?

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