Formycon and Fresenius Kabi Reach Settlement with Johnson & Johnson for FYB202 in Europe and Canada

On March 18, 2024, Formycon AG and Fresenius Kabi announced a settlement agreement with Johnson & Johnson regarding the commercialization of FYB202, their biosimilar candidate to Stelara® (ustekinumab), in Europe and Canada. The specific terms of this agreement have not been disclosed.

Nicola Mikulcik, Chief Business Officer of Formycon AG, highlighted the settlement as a crucial step towards expanding patient access to vital treatments. This agreement, following a previous settlement for the US market, aims to provide patients with more affordable, high-quality treatment options for several immune-mediated disorders.

FYB202 targets interleukin-12 and interleukin-23 and is intended to treat conditions like plaque psoriasis, Crohn's disease, and ulcerative colitis. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are currently reviewing its marketing authorization applications, submitted in September 2023 and November 2023, respectively. A global license agreement was confirmed in February 2023, positioning Fresenius Kabi to market FYB202 upon regulatory approval.