FDA Approves Otulfi, an Ustekinumab Biosimilar

Fresenius and its operating company, Fresenius Kabi, alongside their licensing partner Formycon, have announced that the U.S. Food and Drug Administration (FDA) has approved OtulfiTM (ustekinumab-aauz), a biosimilar of Stelara® (ustekinumab). OtulfiTM is approved for treating several conditions, including Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This approval follows the recent endorsement from the European Commission.

In February 2023, Fresenius Kabi and Formycon entered into a global commercialization agreement for the ustekinumab biosimilar, targeting key global markets. This partnership is a significant step for both companies as they aim to expand their reach in the biopharmaceutical sector. According to a patent settlement involving Formycon, Fresenius Kabi, and Johnson & Johnson, Fresenius Kabi has secured the rights to market OtulfiTM in the United States by February 22, 2025, at the latest.

Fresenius Kabi is focused on strengthening its position in the biopharma industry, crucial for its #FutureFresenius initiative. The company is committed to broadening its portfolio and maintaining its momentum in the market through strategic partnerships and significant product launches like OtulfiTM.

OtulfiTM (ustekinumab-aauz) is a trademark owned by Fresenius Kabi Deutschland GmbH in selected regions, while Stelara® is a registered trademark of Johnson & Johnson.