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Expert Analysis

2014 Year In Review Of US Biosimilar Activity

Law360, New York ( December 10, 2014, 2:52 PM EST) -- This year witnessed significant activity in the U.S. with respect to biosimilars. Highlights include issuance by the U.S. Food and Drug Administration of two new guidances, further debate over the naming of biosimilars, acceptance by the FDA of the first biosimilar application, publication of the "Purple Book" and continued legal wrangling over the so-called patent dance patent resolution provisions added to the Public Health Service Act by the Biologics Price Competition and Innovation Act of 2009....

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