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Expert Analysis

FDA Biosimilar Policy: More Questions, More Answers

Law360, New York (May 27, 2015, 11:48 AM EDT) -- 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 This draft guidance arrives on the heels of the April 28 release of three final biosimilar guidance documents, which also included a Q&A regarding implementation of the BPCI Act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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