FDA accepts Apotex biosimilar application

Apotex Inc., a rising competitor in the global biosimilars market, announced today that the US Food and Drug Administration has accepted for filing the company’s application for Filgrastim [Grastofil™], a biosimilar version of Amgen’s Neupogen®. This product has been jointly developed with Intas Pharmaceuticals Ltd. This is the second follow-on biologic FDA submission for Apotex via the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA). Apotex also has a 351k biosimilar application for the long acting pegylated formulation of filgrastim currently under FDA review. Apotex is the only company to date to have two biosimilar filgrastim applications (pegfilgrastim and filgrastim) currently under active review by FDA. Filgrastim is used to help cancer patients taking chemotherapies fight infections and fever by boosting white blood cell counts. According to Symphony Health Solutions, Neupogen® had approximately $1-billion in sales in calendar year 2014.

Read the source article at PipelineReview.com

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