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Biosimilars Law Blog

Monthly Archives: March 2016

Posted in Biosimilars Patent Exchange, News & Events

FDA Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings

FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for moving protein products currently approved under the drug statute (section 505 of the Food, Drug and Cosmetic Act) to the biologics system (section 351 of the Public Health Service Act).