Fresenius Kabi and Formycon secure U.S. License Date for Ustekinumab biosimilar candidate

Fresenius Kabi and Formycon have entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed Ustekinumab biosimilar in the United States. Subject to regulatory approval, the settlement grants an entry date for FYB202 in the United States no later than April 15, 2025. 

FYB202 is an Ustekinumab biosimilar candidate that references Johnson & Johnson’s Stelara®*, a human monoclonal antibody for the treatment of immune-mediated disorders. 

* Stelara® is a registered trademark of Johnson & Johnson