Fresenius Kabi and Formycon Announce FDA Submission for FYB202, a Ustekinumab Biosimilar Candidate

Fresenius Kabi and its license partner Formycon have made a significant announcement regarding the U.S. Food and Drug Administration (FDA) accepting for review the Biologics License Application (BLA) for FYB202. This biosimilar candidate is designed to reference Johnson & Johnson’s Stelara®, a human monoclonal antibody used in the treatment of immune-mediated disorders.

The acceptance of the FDA submission highlights the commitment of Fresenius Kabi and Formycon to enhancing patient access to high-quality biopharmaceuticals across the globe. This development is a step forward in the availability of biosimilar treatments, potentially offering more options for patients with immune-mediated conditions.