FDA Approves a New Pegfilgrastim Biosimilar for Febrile Neutropenia

Pegfilgrastim-fpgk has been approved by the FDA for patients with febrile neutropenia following data which revealed it to have a high degree of similarity with its reference product.

The FDA has granted approval to pegfilgrastim-fpgk (Stimufend), a biosimilar of pegfilgrastim (Neulasta), as a treatment option for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, according to Fresenius Kabi.1

Pegfilgrastim-fpgk works as a leukocyte growth factor which aims to decrease the incidence of infection induced by febrile neutropenia. Pegfilgrastim-fpgk, is the first biosimilar from Fresenius Kabi to be approved by the FDA.

Previously in March 2022, the European Commission granted a marketing authorization to pegfilgrastim-fpgk for all approved indications of the reference medicine. Following this FDA approval, the company is expected to launch the agent in a prefilled syringe and in an on-body injector early next year.2

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

The pegfilgrastim biosimilar is designed to help patients with non-myeloid cancer by stimulating the growth of select white blood cells. This supportive care medicine allows aids in the prevention of and fight against infections which are often associated with myelosuppressive chemotherapy.

According to Fresenius Kabi, pegfilgrastim-fpgk is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Approval for pegfilgrastim was based on a review of comprehensive data on pegfilgrastim-fpgk which showed that the pegfilgrastim biosimilar elicited a high degree of similarity with the reference product.

Findings from these data showed that there were not any clinically meaningful differences in safety and immunogenicity between the 2 products assessed.

“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,” added Michael Schönhofen, PhD, 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 healthcare system in the United States.”

  1. Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend® (pegfilgrastim). News release. Fresenius Kabi. September 6, 2022. Accessed September 7, 2022. https://bit.ly/3ej0TU6
  2. Fresenius Kabi receives European Commission approval for its pegfilgrastim biosimilar Stimufend®. News release. Fresenius Kabi. March 30, 2022. Accessed September 7, 2022. https://bit.ly/3eioG6D