Munich, Germany – Formycon AG (FSE: FYB) and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson & Johnson concerning the commercialization of FYB202, a biosimilar to Stelara®1 (ustekinumab), in Europe and Canada. It was agreed to keep the terms of the agreement confidential.

Nicola Mikulcik, Chief Business Officer of Formycon AG, commented: “Achieving this settlement is testament to our strategic approach of ensuring we make early preparations to expand patient access to critical treatments. Our aim is to make a significant difference in patients’ lives by providing them with reliable, high-quality, and affordable treatment options. Following the settlement for the US, this is another important step that underlines the joint effort of Formycon and Fresenius Kabi, and it solidifies our position to make FYB202 accessible in key global markets.”

FYB202 is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 and is used for the treatment of various severe immune-mediated disorders. Stelara® is approved for the treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. The marketing authorization application for FYB202 was accepted for review by the European Medicines Agency (EMA) in September 2023 and by the U.S. Food and Drug Administration (FDA) in November 2023. In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement for the ustekinumab biosimilar candidate FYB202, under which FYB202 will be marketed by Fresenius Kabi in key global markets following successful approval.

1)Stelara® is a registered trademark of Johnson & Johnson.