FDA calls one Myozyme different from another
Executive Summary
FDA tells Genzyme that Myozyme for Pompe's disease made at the firm's 160-liter bioreactor scale is a different product from the same drug made at the 2,000-liter scale, which means approval of the 2,000-liter drug will be delayed - a move that could heighten concerns about the agency's powers regarding biosimilars. Regulators say the carbohydrate structure distinguishes the two Myozymes. Genzyme will put together a new BLA for the 2,000-liter version. The Biotechnology Industry Organization declines comment about FDA leeway and pending biosimilars legislation, saying the questions relate to an individual BIO member's news
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