Amneal achieves third US biosimilar approval with Fylentra

30 May 2022

US drugmaker Amneal (NYSE: AMRX) has announced that the US Food and Drug Administration (FDA) has approved the company’s Biologics License Application (BLA) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta.

The Amneal’s biosimilar version of Amgen’s (Nasdaq: AMGN) Neulasta will be marketed under the proprietary name Fylentra.

Fylentra was developed in collaboration with Chicago-based Kashiv Biosciences. 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.

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