Sandoz Working With FDA To Resolve Questions About Neulasta Biosimilar

July 20, 2016 at 6:58 PM
FDA has raised questions about Sandoz's biosimilar application for Amgen's Neulasta, Novartis revealed in an interim financial report Tuesday (July 19). The company received a complete response letter concerning the application, and Sandoz is working with the agency to address remaining questions. The biosimilar is also at the center of a lawsuit brought by Amgen in March to over the patent-dispute-resolution provisions of the BPCIA. Amgen requested the court declare that Sandoz failed to comply with the biosimilar pathway's "mandatory...


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