FDA Approves Stimufend, a Biosimilar to Neulasta

Fresenius Kabi expects to launch Stimufend as a prefilled syringe early in 2023.

The FDA has approved Fresenius Kabi’s 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 as a prefilled syringe early next year. Stimufend is a biosimilar of Amgen’s Neulasta. The company is also developing on-body injector for Stimufend.

“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,” Michael Schönhofen, Ph.D., Fresenius Kabi’s chief operating officer. “With our portfolio, we contribute to the broader adoption of biosimilars and to a sustainable healthcare system in the United States.”

Stimufend is Fresenius Kabi’s first U.S.-approved therapy in its biosimilar portfolio.

Pegfilgrastim biosimilar is a supportive care medicine for patients with non-myeloid cancer. It stimulates the growth of certain white blood cells, which are essential to prevent or fight infections, a common life-threatening risk in patients receiving myelosuppressive chemotherapy.

The approval for Stimufend is 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

Stimufend received European Commission approval in March 2022.