Fresenius : Kabi receives U.S. FDA approval for biosimilar Stimufend®* (pegfilgrastim)

The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi'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.
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.

* Stimufend® (pegfilgrastim) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stimufend is a pegfilgrastim biosimilar medicine of Neulasta®, which is a registered trademark of Amgen Inc.