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Drain the swamp
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) established a framework for FDA approval of biosimilars. It also provided a system for litigation of patent disputes involving those products. Recently on November 19, 2020, FDA issued guidance entitled, “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition […]