FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar

The FDA has approved Stimufend (pegfilgrastim-fpgk), a biosimilar referencing Neulasta, according to a statement from the developer, Fresenius Kabi. The biosimilar marks the sixth pegfilgrastim biosimilar to receive regulatory approval.

The approval is also the second pegfilgrastim biosimilar, the fourth oncology biosimilar, and the fifth biosimilar overall to be approved by the FDA in 2022, following those for Cimerli (ranibizumab-eqrn) in August, Fylnetra (pegfilgrastim-pbbk) in June, Alymsys (bevacizumab-maly) in April, and Releuko (filgrastim-ayow) in March. It’s also the first biosimilar developed by Fresenius Kabi to be approved for use in the United States.

Pegfilgrastim products are granulocyte colony-stimulating factor (G-CSF) agents that are used in patients with non-myeloid malignancies undergoing myelosuppressive anticancer drugs who are at risk of developing febrile neutropenia.

Fresenius Kabi said that it expects to launch Stimufend in a prefilled syringe in early 2023. The company is also looking to get the product approved in an on-body injector to compete against the on-body injector product for Neulasta (Neulasta Onpro). In the fourth quarter of 2019, Neulasta Onpro represented nearly 45% of all long-acting G-CSF prescriptions, considerably higher than those for pegfilgrastim biosimilars (29.8%).

“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. With our portfolio, we contribute to the broader adoption of biosimilars and to a sustainable healthcare system in the U.S.,” said Michael Schönhofen, PhD, chief operating officer of Fresenius Kabi and member of the Fresenius Kabi Management Board.

The approval was based on a review containing a comprehensive data package demonstrating the comparable safety and efficacy of Stimufend vs Neulasta. Stimufend was also granted marketing authorization by the European Commission in March 2022.

In addition to Stimufend, biologics license applications for Fresenius Kabi’s tocilizumab (Actemra) biosimilar candidate (MSB11456) and adalimumab candidate (Idacio) referencing Humira are currently under review with the FDA. Fresenius Kabi also launched Idacio on the Canadian market in February 2021.