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Biosimilars Law Blog

Monthly Archives: July 2016

Posted in Biosimilar labeling, News & Events

FDA Denies Three Petitions on Biosimilar Labeling: Refers Petitioners to Guidance Process

The U.S. Food and Drug Administration denied three pending petitions regarding biosimilar labeling without substantively addressing most of the issues raised in the petitions. FDA’s denial letter indicates that biosimilar labeling guidelines are still in flux while FDA works to finalize its March 2016 Draft Guidance for Industry: Labeling for Biosimilar Products. According to FDA,