Analysis: Recall could make FDA more cautious about biosimilars

02/26/2013 | Forbes

The recall of Affymax's anemia drug Omontys could prompt more caution from the FDA as it develops a pathway for the approval of biosimilar drugs, former FDA official Dr. Scott Gottlieb writes. "The agency has years of experience with biological agents that simulate red blood cell production, and the inability to ferret out the risks with Omontys is likely to underscore how hard this science remains," he writes.

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