U.S. FDA Approval for OtulfiTM*, an Ustekinumab Biosimilar

After having received the European Commission approval just recently, Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the United States (U.S.) Food and Drug Administration (FDA) has approved OtulfiTM (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®** (ustekinumab). OtulfiTM is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. In accordance with the patent settlement between Formycon, Fresenius Kabi and Johnson & Johnson, Fresenius Kabi has the right to market OtulfiTM in the U.S. no later than February 22, 2025.

Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma business, which is a substantial cornerstone of #FutureFresenius.

* OtulfiTM (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
** Stelara® is a registered trademark of Johnson & Johnson