Tag: Amneal Pharmaceuticals

FDA, Regulations

FDA Approves Fylnetra (pegfilgrastim-pbbk), a Biosimilar to Neulasta

May 27, 2022


Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Biologics License Application (“BLA”) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the […]