Fresenius Kabi snags its first biosimilar approval

Sept. 7, 2022

German biopharma Fresenius Kabi announced that the FDA has approved its pegfilgrastim biosimilar, Stimufend, for use in patients with non-myeloid malignancies and who are receiving immunosuppressive anti-cancer drugs. 

Stimufend is the company’s first approved U.S. biosimilar, but the sixth FDA-approved biosimilar for Amgen's Neulasta. Pegfilgrastim drugs act as granulocyte colony-stimulating factor agents, which helps decrease the chance of infection in cancer patients due to a low white blood cell count by treating neutropenia, or a lack of certain white blood cells caused by common cancer therapies.

In order to qualify for biosimilar status, Fresenius had to demonstrate comprehensive data supporting a high degree of similarity with the reference product. The randomized, double-blind trial included 336 participants and compared the immunogenicity and safety of Stimufend against Neulasta in healthy adults. 

The approved drug joins other new biosimilars on the U.S. market, like the many Humira biosims going live in 2023. 

Neulasta sales have already started to steadily decrease for Amgen, going from $4.5 billion in 2020 to $2.2 in 2020.