FDA Approves Fresenius Kabi’s Pegfilgrastim Biosimilar Stimufend

On September 6, Fresenius Kabi announced that it had received FDA approval for Stimufend® (pegfilgrastim-fpgk). This agent will be marketed in 2023, according to the company.

The first US biosimilar approval for Fresenius Kabi, Stimufend is indicated for use in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia.

According to Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer, “The FDA approval of our pegfilgrastim biosimilar is an important step to better support the treatment experience and clinical outcomes of cancer patients in the United States.”

Stimufend enters a crowded pegfilgrastim biosimilar category, as the sixth entry. The company intends to launch the prefilled syringe formulation early next year, and did not mention any pricing. Interestingly, the press release announcing the approval did mention that Fresenius Kabi is developing an on-body injector to compete with Neulasta OnPro®.   

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