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 proprietary name Fylnetra.
Fylnetra was developed in collaboration with Kashiv Biosciences, LLC, located in Chicago, Illinois. It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy.
