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FDA approves Pfizer's Neupogen biosimilar

July 20, 2018 10:22 PM UTC

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label.

The approval comes two days after FDA Commissioner Scott Gottlieb said in a speech unveiling FDA's Biosimilars Action Plan that the U.S. biosimilars market is “anemic.” He noted that of 11 FDA-approved biosimilars, only three are marketed (see "FDA Aims to Juice 'Anemic' Biosimilars Market")...

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