The U.S. Food and Drug Administration (FDA) has approved Otulfi, an ustekinumab biosimilar referencing Stelara, from Fresenius Kabi and Formycon AG.
Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Otulfi is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
This marks the fourth FDA-approved biosimilar for Stelara.
“The FDA approval of Otulfi, Fresenius Kabi’s fourth biosimilar product in the U.S. market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the U.S. and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally,” says Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, in a news release.
In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets.
The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to Stelara in patients with moderate to severe psoriasis vulgaris. Otulfi was approved for both subcutaneous and intravenous formulations.
