Fresenius Kabi and Formycon Announce FDA Submission Acceptance for Review for Ustekinumab Biosimilar Candidate Announcement of Fresenius Kabi and its license partner Formycon: FDA has accepted Ustekinumab biosimilar candidate for review.

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 Related News Biopharma by Fresenius Kabi We offer affordable, high-quality, effective, and safe biopharmaceuticals for patients with autoimmune diseases and cancer. Learn more at Fresenius Kabi! Employee Story Cafè Latte with Ivett Jelinek: Biosimilars and Scientific Purpose Meet Ivett Jelinek, Director Clinical Affairs at Fresenius Kabi SwissBioSim and learn how she advances biosimilars for patient access. Our Portfolio Discover Fresenius Kabi's portfolio in Pharma, Nutrition, MedTech and Biopharma. Explore our innovative solutions for improved healthcare results. Find out more about our Biopharma portfolio

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