On September 6, 2022 Fresenius Kabi reported The U.S. Food and Drug Administration (FDA) has approved it’s pegfilgrastim biosimilar, Stimufend, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia (Press release, Fresenius, SEP 6, 2022, View Source [SID1234619035]).

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The company expects to launch the product in a prefilled syringe next year and additionally in an on-body injector following FDA approval.
This is another important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing Fresenius Kabi’s first U.S. approved therapy in its biosimilar portfolio.