Fresenius Kabi and its license partner Formycon announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for FYB202, a Ustekinumab biosimilar candidate. FYB202 references Johnson & Johnson’s Stelara®*, a human monoclonal antibody for the treatment of immune-mediated disorders.
The FDA submission acceptance underscores Fresenius Kabi’s and Formycon’s unwavering commitment to improving patient access to high-quality biopharmaceuticals worldwide. For more information, please see the website of Fresenius Kabi.
* Stelara® is a registered trademark of Johnson & Johnson