FDA Approves Pegfilgrastim Biosimilar for Febrile Neutropenia

The FDA has approved the biosimilar pegfilgrastim-fpgk (Stimufend) for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.¹

Pegfilgrastim-fpgk is a biosimilar medicine of pegfilgrastim (Neulasta), and the agent is a leukocyte growth factor indicated to decrease the incidence of infection induced by febrile neutropenia. Pegfilgrastim-fpgk is the first biosimilar from Fresenius Kabi to receive approval from the FDA, and the company expects to launch the agent in a prefilled syringe in early 2023 and in an on-body injector following FDA approval.

“This is a strategic milestone for Fresenius Kabi in one of the most important and fast-growing markets for biopharmaceuticals,” Michael Sen, chief executive officer (CEO) of Fresenius Kabi and designated CEO of Fresenius, stated in a press release. “The company consequently expands its presence and position in the highly attractive U.S. biosimilars marketplace in line with Vision 2026.”

The pegfilgrastim biosimilar is designed as a supportive care treatment for patients with non-myeloid cancer. By stimulating the growth of select white blood cells, it can aid in the prevention or fight against infections associated with myelosuppressive chemotherapy.

The approval was based on a review of data on pegfilgrastim-fpgk that showed that the biosimilar demonstrated a high degree of similarity with the reference product, pegfilgrastim. Findings showed that there were no clinically meaningful differences in safety and immunogenicity between the two products.

“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, PhD, chief operating officer of Fresenius Kabi, stated in a press release. “With our portfolio, we contribute to the broader adoption of biosimilars and to a sustainable healthcare system in the U.S.”

In March 2022, the European Commission granted a marketing authorization to pegfilgrastim-fpgk for all approved indications of the reference medicine.²

References

1. Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend® (pegfilgrastim). News release. Fresenius Kabi. September 6, 2022. Accessed September 6, 2022. https://bit.ly/3eszMpU
2. Fresenius Kabi receives European Commission approval for its pegfilgrastim biosimilar Stimufend®. News release. Fresenius Kabi. March 30, 2022. Accessed September 6, 2022. https://bit.ly/3TNerrb