EMA has accepted marketing authorization application for Ustekinumab biosimilar candidate of Fresenius Kabi and Formycon

Fresenius Kabi and its license partner Formycon announced today that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for FYB202, an Ustekinumab biosimilar candidate. FYB202 references Johnson & Johnson’s Stelara^®*, a human monoclonal antibody for the treatment of immune-mediated disorders. 

Fresenius Kabi is the commercialization partner. The acceptance of the MAA for review marks another milestone in the company’s Vision 2026 growth strategy.

For more information, please see the website of Fresenius Kabi. 

* Stelara^® is a registered trademark of Johnson & Johnson