FDA Approves Fifth Pegfilgrastim Biosimilar, Fylnetra

The FDA has approved the fifth pegfilgrastim biosimilar for the US market, Amneal Pharmaceuticals and Kashiv Biosciences’ Fylnetra (pegfilgrastim-pbbk), referencing Neulasta.

Fylnetra is the third biosimilar developed by Amneal Pharmaceuticals and the second for Kashiv Biosciences to be authorized for US marketing. The approval follows those for Releuko (filgrastim-ayow) and Alymsys (bevacizumab-maly). All 3 approvals have been for oncology biosimilars.

“This is our third US biosimilar approval this year, and we are very enthusiastic about our future in the fast growing $28 billion US biosimilars market,” said Chirag and Chintu Patel, co-chief executive officers of Amneal Pharmaceuticals, in a company statement. "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."

Pegfilgrastim products are used to treat or prevent febrile neutropenia in patients with cancer being treated with chemotherapy. Amneal Pharmaceutcials said that it expects to launch Releuko, Alymsys, and Fylnetra during the second half of 2022.

“Building on our successful partnership with the recent approval of our first biosimilar, Releuko, we are pleased to receive approval for our second biosimilar,” said Chandramauli Rawal, MBBS, chief operating officer for Kashiv Biosciences. "Kashiv is one of a few domestic companies to manufacture and launch multiple biosimilars in the United States. Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years. I would like to extend a humble thank you to our highly talented team, without whom this would not have been possible."

Fylnetra will join Nyvepria (pegfilgrastim-apgf), Ziextenzo (pegfilgrastim-bmez), Udenyca (pegfilgrastim-cbqv), and Fulphila (pegfilgrastim-jmdb) in competing against the originator in the United States. Fulphila was the first pegfilgrastim biosimilar to be approved in June 2018, followed by Udenyca in November 2018, Ziextenzo in November 2019, and Nyvepria in June 2020.