CHMP positive for Pyzchiva (ustekinumab biosimilar) to treat psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease. - Samsung Bioepis + Sandoz
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pyzchiva( formerly SB 17), intended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease in adults. The applicant for this medicinal product is Samsung Bioepis NL B.V.
Pyzchiva will be available as 45 mg and 90 mg solutions for injection and a 130 mg solution for infusion. The active substance of Pyzchiva is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05). Ustekinumab is a fully human IgG1? monoclonal antibody that binds to the shared p40 protein subunit of interleukin (IL)-12 and IL-23, thereby preventing them from binding to the IL?12Rbeta1 receptor protein expressed on the surface of immune cells. By doing so, ustekinumab may exert its clinical effects in psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease through interruption of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases.
Pyzchiva is a biosimilar medicinal product. It is highly similar to the reference product Stelara (ustekinumab), which was authorised in the EU on 15 January 2009. Data show that Pyzchiva has comparable quality, safety and efficacy to Stelara.
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