Partners Amneal and Kashiv Score Approval From FDA for Their Pegfilgrastim Biosimilar

On May 27, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration granted approval to Fylnetra™ (pegfilgrastim-pbbk), a new biosimilar that will launch later this year.

Amneal has been busy this year in the biosimilar area: This is its third biosimilar approval since January 1. The two earlier approvals, for filgrastim and bevacizumab biosimilars, will also launch in the second half of the year, according to the press release from Amneal.

Fylnetra was the result of a development collaboration with Kashiv Biosciences (Kashiv was also Amneal’s development partner for its filgrastim biosimilar Releuko®).

This is an extremely competitive drug category, with Amgen’s reference product Neulasta® and Neulasta OnPro® still hanging onto roughly two thirds of the marketshare. Other manufacturers Coherus Biosciences, Sandoz, Pfizer, and Viatris account for about $1 billion in annual U.S. sales. And entries from Fresenius Kabi and Lupin may still enter the market before the end of the year. As previously reported, Coherus hopes to introduce a direct competitor to OnPro in 2023.

Launch pricing for Fylnetra has not yet been announced by Amneal.   

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