Fresenius Kabi and Formycon Announce FDA Submission Acceptance for Review for Ustekinumab Biosimilar Candidate

November 30, 2023

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

scientist in lab working with test tubes

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