FDA Approves Stimufend, Biosimilar for Pegfilgrastim-fpgk

In the first approved biosimilar for Fresenius Kabi, officials with the FDA have approved Stimufend, a biosimilar of pegfilgrastim-fpgk, indicated to reduce the incidence of infection as manifested by febrile neutropenia in patients undergoing chemotherapy.

Stimufend is indicated for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Fresenius Kabi expects to launch the product in a prefilled syringe in early 2023 and as an on-body injector following FDA approval, according to a press release.

The biosimilar is a supportive care medication for patients and stimulates the growth of certain white blood cells, which are necessary to prevent or fight infections. Depletion of these white blood cells is a common life-threatening risk in patients receiving myelosuppressive chemotherapy.

“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,” said Michael Schonhofen, chief operating officer of Fresenius Kabi, in the press release. “With our portfolio, we contribute to the broader adoption of biosimilars and to a sustainable health care system in the US.”

The approval was based on a review of a comprehensive data package and a totality of evidence that demonstrated a high degree of similarity with the reference product. No clinically meaningful differences in safety and immunogenicity were observed.

It is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Earlier in 2022, the company received marketing authorization from the European Commission, and it intends to launch the prefilled syringe in Europe in the fall.

“This is a strategic milestone for Fresenius Kabi in one of the most important and fast-growing markets for biopharmaceuticals,” said Michael Sen, CEO of Fresenius Kabi and designated CEO of Fresenius, in the press release.

REFERENCE

Fresenius Kabi receives US FDA approval for biosimilar Stimufend (pegfilgrastim). News release. Fresenius Kabi; September 6, 2022. Accessed September 6, 2022. https://www.fresenius-kabi.com/news/fresenius-kabi-receives-us-fda-approval-for-biosimilar