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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.
Drugs to Watch: Mental Health Conditions
April 11th 2024The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
