Outside Publication

FDA Biosimilar Policy: More Questions, More Answers, Law360

May 27, 2015

On May 13, 2015, the U.S. Food and Drug Administration released yet another biosimilar Q&A guidance document — Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. This draft guidance arrives on the heels of the April 28 release of three final biosimilar guidance documents, which also included a Q&A regarding implementation of the BPCI Act of 2009.

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