Continuing Biopharma Growth with U.S. and EU Launch of Ustekinumab Biosimilar

Fresenius announced today that its Operating Company Fresenius Kabi’s ustekinumab biosimilar Otulfi® (ustekinumab-aauz), developed by Formycon AG, is now available in the United States and European Union. Otulfi® is an ustekinumab biosimilar for the reference product Stelara® (ustekinumab). 

In February 2023, Fresenius Kabi and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. In September 2024, U.S. FDA and EC approval for both subcutaneous and intravenous formulations was received. Otulfi® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis in the U.S. Being Fresenius’ fourth biosimilar on the market, the company continues the growth path of its BioPharma platform in line with #FutureFresenius.