CHMP positive recommendation for Wezenla (ustekinumab biosimilar), intended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults. -Amgen
On 25 April 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Wezenla, intended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.
The applicant for this medicinal product is Amgen Technology (Ireland) UC.
Wezenla will be available as 45 and 90 mg solution for injection and 130 mg concentrate for solution for infusion. The active substance of Wezenla is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05). Ustekinumab is a human IgG1? monoclonal antibody that binds to the p40 protein subunit shared by interleukin-12 (IL-12) and IL-23. By doing so, it prevents them from binding to the IL 12R?1 receptor protein expressed on the surface of immune cells. Ustekinumab may therefore exert its clinical effects in psoriasis, psoriatic arthritis and Crohn’s disease through inhibition of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases.
Wezenla 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 Wezenla has comparable quality, safety and efficacy to Stelara.
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