Fresenius Kabi gains first US biosimilar approval, with Stimufend

7 September 2022

Germany-headquartered drugmaker Fresenius Kabi says that the US Food and Drug Administration (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, a biosimilar to Amgen’s (Nasdaq: AMGN) Neulasta, in a prefilled syringe early next year and in an on-body injector following FDA approval.

According to IQVIA, US annual sales for pegfilgrastim for the 12 months ended March 2022 were $3.1 billion, $1.0 billion of which represented biosimilar sales.

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