Amneal Pharma Announces FDA Approval For Its Biosimilar Referencing Neulasta

Amneal Pharmaceuticals, Inc. (AMRX) announced the FDA has approved the company's Biologics License Application for pegfilgrastim-pbbk, a biosimilar referencing
Neulasta. The product will be marketed under the name FYLNETRA.

FYLNETRA was developed in collaboration with Kashiv Biosciences. It is used to treat neutropenia.

The company noted that this marks the third biosimilar approval Amneal received this year for products used in oncology. Amneal expects to launch these three products over the second half of 2022.

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