European Commission Approves FYB202, Ustekinumab Biosimilar

Fresenius, in collaboration with its operating company Fresenius Kabi and license partner Formycon, has announced that the European Commission (EC) has granted marketing authorization for FYB202. FYB202 is a biosimilar candidate to Stelara® (ustekinumab), which is used in the treatment of various serious inflammatory conditions.

In early 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate. This partnership covers key international markets, aiming to bring the biosimilar to patients worldwide. Following this, in March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson regarding the commercialization of their ustekinumab biosimilar in Europe and Canada. The specifics of this agreement remain confidential.

Fresenius Kabi is continuing its strategic efforts to strengthen its Biopharma business, which is a crucial part of its future growth plans. The approval of FYB202 by the European Commission marks a significant milestone in these efforts, further enhancing the company's position in the biosimilars market.

Stelara® is a registered trademark of Johnson & Johnson.