Big Molecule Watch
May 27, 2022

Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA (pegfilgrastim-pbbk)

Amneal announced today that the U.S. Food and Drug Administration has approved its Biologics License Application for FYLNETRA (pegfilgrastim-pbbk), a biosimilar referencing NEULASTA®.  FYLNETRA, developed in collaboration with Kashiv Biosciences, LLC, 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.

Earlier this year, Amneal received approval of RELEUKO® (filgrastim-ayow), a filgrastim biosimilar referencing NEUPOGEN®, and AlYMSYS® (bevacizumab-maly), a bevacizumab biosimilar referencing AVASTIN®.   Amneal states that it “expects to launch these three products over the second half of 2022, along with a full patient support program.”  According to Amneal’s Co-Chief Executive Officers, Chirag and Chintu Patel, “[t]his is our third U.S. biosimilar approval this year and we are very enthusiastic about our future in the fast growing $28 billion U.S. biosimilars market.  Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible.”

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