European Commission Approval for FYB202, an Ustekinumab Biosimilar

Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the European Commission (EC) granted marketing authorization for FYB202, a biosimilar candidate to Stelara® (ustekinumab) indicated for the treatment of several serious inflammatory diseases.

In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential.

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

Stelara® is a registered trademark of Johnson & Johnson