CHMP recommends Fymskina (FYB 202), a biosimilar candidate to Stelara (ustekinumab) indicated for the treatment of several serious inflammatory diseases.Fresenius Kabi.
Formycon AG and its commercialization partner Fresenius Kabi jointly announce, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of Fymskina ( FYB 202 ), a biosimilar candidate to Stelara (ustekinumab) indicated for the treatment of several serious inflammatory diseases
Fymskina will be available as 45 or 90 mg solution for injection in pre-filled syringe and 130 mg concentrate for solution for infusion. The active substance of Fymskina is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05).
Ustekinumab is a fully human IgG1monoclonal antibody that binds to the p40 subunit of interleukin IL 12 and 23, thereby preventing them from binding to the IL 12Rbeta1 receptor expressed on the surface of immune cells. By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.
Fresenius Kabi is commercialization partner of Formycon AG for FYB 202 in key global markets.
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