FDA Approves Fifth Neulasta Biosimilar

The FDA approval for Fylnetra represents the fifth approval for a biosimilar referencing Neulasta (pegfilgrastim) in the United States.

The FDA approved Fylnetra (pegfilgrastim-pbbk), a biosimilar referencing Neulasta, developed by Amneal Pharmaceuticals and Kashiv Biosciences.

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.

Fylnetra represented the fifth pegfilgrastim biosimilar approval in the United States, the third US biosimilar approval for Amneal Pharmaceuticals, and the second drug approval for Kashiv Biosciences.

The approvals comes after Releuko (filgrastim-ayow), which was approved in March 2022, and Alymsys (bevacizumab-maly), which was approved in April 2022. Releuko references Neupogen and Alymsys is based on Avastin. All 3 are indicated for use in patients with cancer.

“Building on our successful partnership with the recent approval of our first biosimilar, Releuko, we are pleased to receive approval for our second biosimilar…. 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,” said Chandramauli Rawal, MBBS, chief operating officer for Kashiv Biosciences, in a company statement.

In addition to Fylneta, the FDA approved Nyvepria (pegfilgrastim-apgf) in June 2020, Ziextenzo (pegfilgrastim-bmez) in November 2019, Udenyca (pegfilgrastim-cbqv) in November 2018, and Fulphila (pegfilgrastim-jmdb) in June 2018.