CHMP recommends Otulfi(ustekinumab biosimilar) for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Otulfi, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease. The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH
Otulfi 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 Otulfi is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05). Ustekinumab is a fully human IgG1? monoclonal 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 and Crohn’s disease.
Otulfi 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 Otulfi has comparable quality, safety and efficacy to Stelara (ustekinumab).
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