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Archive: 09 Apr 2015
Novartis Wins Appeal for First Biosimilar to Go On Sale in US
Novartis International has won FDA approval for a biosimilar of an existing drug. The drug, a copy of Amgen’s Neupogen, is designed to boost white blood cell counts in certain patients. An abbreviated FDA approval pathway for biologic medical products that share most of their properties with an existing, approved biologic product was created by […]