Fresenius Kabi and Formycon Receive European Approval for Ustekinumab Biosimilar FYB202

Fresenius Kabi and Formycon Receive European Approval for Ustekinumab Biosimilar FYB202

(IN BRIEF) Fresenius Kabi, in collaboration with Formycon, has received approval from the European Commission (EC) for FYB202, a biosimilar of ustekinumab (marketed as Stelara® by Johnson & Johnson). This biosimilar is approved for the treatment of serious inflammatory diseases. The partnership between Fresenius Kabi and Formycon, established in February 2023, aims to commercialize the biosimilar in key global markets, with a specific settlement agreement reached with Johnson & Johnson for Europe and Canada in March 2024. Fresenius Kabi continues to grow its biopharma business, a significant part of its long-term strategy.

(PRESS RELEASE) BAD HOMBURG, 27-Sep-2024 — /EuropaWire/ — Fresenius, through its biopharmaceutical arm Fresenius Kabi, along with its licensing partner Formycon, announced that the European Commission (EC) has granted marketing authorization for their ustekinumab biosimilar, FYB202. This biosimilar is intended for the treatment of serious inflammatory conditions, offering an alternative to Stelara® (ustekinumab).

The approval comes as part of a strategic global commercialization partnership formed in February 2023 between Fresenius Kabi and Formycon. The collaboration covers key global markets. Furthermore, in March 2024, the companies reached a settlement agreement with Johnson & Johnson, allowing the commercialization of FYB202 in Europe and Canada. Details of this agreement remain confidential.

Fresenius Kabi continues to strengthen its presence in the biopharmaceutical sector, with its expanding biosimilar portfolio forming a key element of the company’s strategic growth plan, #FutureFresenius.

Stelara® is a registered trademark of Johnson & Johnson.

Media Contact:

Tel: +49 6172 686 0
email: communication@fresenius-kabi.com

SOURCE: Fresenius Kabi AG