Posted by Michael Wonder on 06 Sep 2022
Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend (pegfilgrastim-fpgk)
6 September 2022 - Fresenius Kabi’s first approved U.S. biosimilar.
Fresenius Kabi announced today that the US FDA has approved its biosimilar, Stimufend (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
The company expects to launch the product in a pre-filled syringe early next year and in an on-body injector following FDA approval.
