FDA is expected to issue guidance for biosimilars this year

05/9/2011 | Reuters · Hill, The

The FDA likely will release this year a set of guidelines for drugmakers applying for market approval of biogenerics, said Janet Woodcock, head of the agency's Center for Drug Evaluation and Research. The FDA is "meeting with companies individually right now and giving them advice on their programs," and the agency is "very interested in providing competition where we have a mandate," Woodcock said. Separately, the FDA is seeking feedback on a proposal to charge a fee before a biosimilar is reviewed.

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