CHMP positive for Absimky (ustekinumab biosimilar) from Accord Healthcare/Intas
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Absimky, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, Crohn’s disease or ulcerative colitis
The applicant for this medicinal product is Accord Healthcare S.L.U.
Absimky will be available as a 45 mg or 90 mg solution for injection in pre-filled syringes and a 130 mg concentrate for solution for infusion. The active substance of Absimky is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05). Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the shared p40 protein subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 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 plaque psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis.
Absimky 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 Absimky has comparable quality, safety and efficacy to Stelara.
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