FDA approves BLA for Releuko biosimilar to Neupogen.- Amneal Pharma
Amneal Pharmaceuticals, Inc. announced the FDA approval of the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen. The product will be marketed under the proprietary name Releuko.
Releuko 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. Amneal expects to launch Releuko in the third quarter of 2022, along with a full patient support program.
The Company is planning for a pegfilgrastim biosimilar referencing Neulasta and a bevacizumab biosimilar referencing Avastin to launch in 2022. Both are being reviewed by the FDA.
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