Positive CHMP opinion for Qoyvolma ( ustekinumab biosimilar) for treatment of plaque psoriasis- Celltrion
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Qoyvolma, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, Crohn’s disease or ulcerative colitis. The applicant is Celltrion Healthcare Hungary Kft.
Qoyvolma will be available as a 45 or 90 mg solution for injection in pre-filled syringes, and a 130 mg concentrate for solution for infusion. The active substance of Qoyvolma is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05). Qoyvolma 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 Qoyvolma has comparable quality, safety and efficacy to Stelara (ustekinumab).
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