Fresenius Kabi Announces FDA Approval of Pegfilgrastim Biosimilar

On September 6, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved STIMUFEND (pegfilgrastim), a biosimilar referencing NEULASTA, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  The company states that it expects to launch the product in the U.S. early next year.  As we previously reported, STIMUFEND received the European Commission’s marketing authorization in March 2022, and according to the press release, Fresenius intends to launch the product in Europe this fall.

This is the first biosimilar developed by Fresenius to receive FDA approval.  STIMUFEND is the sixth biosimilar referencing NEULASTA to receive FDA approval, following the approval of Amneal’s FYLNETRA in May 2022.