In late July, FDA accepted Sandoz’ application for biosimilar filgrastim (Amgen’s Neupogen), marking the first biosimilar filed under the 351k pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). [Sandoz’ Press Release.] [See IPQ Aug. 9, 2012 for a detailed description of Sandoz’ approach to biosimilar development.]
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