FDA approves Pfizer Nivestym, second Neupogen biosimilar

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 July 20 approval followed July 18 remarks by FDA Commissioner Scott Gottlieb, who 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...