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Fresenius Kabi has entered into a global license agreement to commercialize a Ustekinumab biosimilar candidate (FYB202) being developed by Formycon AG. The proposed biosimilar is currently in advanced clinical stage. FYB202 is a biosimilar candidate referencing Johnson & Johnson’s Stelara®*, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. Stelara is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. The global license agreement gives Fresenius Kabi exclusive rights to commercialize the proposed Ustekinumab biosimilar product in key global markets.

*Stelara® is a registered trademark of Johnson & Johnson