FDA Approves Amneal’s Biosimilar of Neulasta


This is the fifth biosimilar of Neulasta and the third biosimilar from Amneal to receive FDA approval.

The FDA has approved Amneal Pharmaceuticals’ biologics license application for Fylnetra (pegfilgrastim-pbbk), a biosimilar referencing Amgen’s Neulasta (pegfilgratim). Fylnetra was developed in collaboration with Kashiv Biosciences. It is used to decrease the risk of infection after chemotherapy.

Four other biosimilars have been approved by the FDA: Fulphila, co-developed by Biocon Biologics and Mylan; Nyvepria, developed by Pfizer; Udenyca, developed by Coherus BioSciences; and Ziextenzo, developed by Sandoz, a division of Novartis.

This marks the third biosimilar approval Amneal received this year for products used in oncology. Earlier this year, the FDA approved Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen, and Alymsys (bevacizumab-maly), a bevacizumab biosimilar referencing Avastin. Amneal expects to launch these three products over the second half of 2022, along with a full patient support program.

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