Stimufend, a Biosimilar to Neulasta, Gets FDA Approval

The Food and Drug Administration (FDA) has approved Stimufend^® (pegfilgrastim-fpgk), a biosimilar to Neulasta^® (pegfilgrastim).

Stimufend, a leukocyte growth factor, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

The approval was based on a review of a comprehensive data package and a totality of evidence demonstrating a high degree of similarity of Stimufend to the reference product, with no clinically meaningful differences in safety and immunogenicity observed.

The product will be supplied as 6mg/0.6mL preservative-free solution in single-dose prefilled syringes for subcutaneous injection. Fresenius Kabi expects to launch Stimufend in a prefilled syringe in early 2023 and in an on-body injector following FDA approval.

Stimufend is the sixth pegfilgrastim biosimilar approved by the FDA. Other approved biosimilars include Fulphila (Mylan), Fylnetra (Amneal), Nyvepria (Pfizer), Udenyca (Coherus Biosciences), and Ziextenzo (Sandoz).

References

1. Fresenius Kabi receives US FDA approval for biosimilar Stimufend^® (pegfilgrastim – fpgk). News release. Fresenius Kabi. Accessed September 6, 2022. https://www.businesswire.com/news/home/20220906005876/en/Fresenius-Kabi-Receives-U.S.-FDA-Approval-for-Biosimilar-Stimufend%C2%AE-pegfilgrastim—fpgk
2. Stimufend. Package insert. Fresenius Kabi; 2022. Accessed September 6, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761173s000lbl.pdf