AMRX - Amneal Kashiv's biosimilar therapy to Amgen's Neulasta gets FDA approval

The U.S. Food and Drug Administration (FDA) approved Amneal Pharmaceuticals' (NYSE:AMRX) and Kashiv Biosciences' Fylnetra, a biosimilar to Amgen's (AMGN) Neulasta. Fylnetra (pegfilgrastim-pbbk) is used to treat neutropenia, a condition that occurs when there are fewer neutrophils, type of white blood cells. The condition is commonly seen in patients undergoing chemotherapy, said the company in a May 27 release. Amneal said Fylnetra was developed in collaboration with Chicago-based Kashiv. Amneal said the approval marks the third biosimilar approval it received this year for products used in oncology. The company's Releuko (filgrastim-ayow), a biosimilar of Amgen's Neupogen; and Alymsys (bevacizumab-maly), a biosimilar to Roche's Avastin was approved earlier. Amneal expects to launch the three products in H2 2022, with a full patient support program.

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Amneal, Kashiv's biosimilar therapy to Amgen's Neulasta gets FDA approval