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FDA on Biosimilars
No interferon beta biosimilars are yet on the market in Europe, but EMA is preparing for that eventuality by soliciting formal comment on a draft guidance it issued January 23. There are two interferon beta-1a drugs—Biogen Idec’s Avonex and Merck Serono’s Rebif—and two interferon beta-1b drugs—Betaseron made by Bayer HealthCare and Novartis’ Extavia, a copy of Betaseron that Novartis pays Bayer royalties to market. The EMA has slowly but surely developed guidelines for different types of biosimilars, while FDA is still working on finalizing the pathway for biosimilar approval in the U.S. The agency says it is in the final stages of issuing a draft guidance, though. What do you think of the situation in the U.S.?