CHMP Endorses FYB202, a Ustekinumab Biosimilar

Fresenius, through its subsidiary Fresenius Kabi, along with its licensing partner Formycon, have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favorable opinion regarding the marketing authorization for FYB202. FYB202 is a biosimilar candidate to Stelara® (ustekinumab), which is prescribed for various severe inflammatory conditions.

In February 2023, Fresenius Kabi and Formycon established a global commercial partnership for the distribution of the ustekinumab biosimilar candidate, targeting major global markets. This collaboration aims to enhance the availability of this biosimilar to patients worldwide.

The recent positive opinion from the CHMP marks a significant milestone in Fresenius Kabi’s ongoing efforts to increase patient access to high-quality biological therapies. The company is focused on expanding its capabilities and product range in the biosimilars sector as part of its broader (Bio)Pharma platform development strategy, known as #FutureFresenius.

Stelara® is a registered trademark of Johnson & Johnson.