Sandoz receives European Commission approval for autoimmune biosimilar

Sandoz, a Novartis division, announced that the European Commission granted marketing authorization to biosimilar Hyrimoz for use in all indications of the reference medicine, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease, uveitis and ulcerative colitis. The approval was based on a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that Hyrimoz matches the reference biologic in terms of safety, efficacy and technical quality. A randomized, double-blind, three-arm, parallel study confirmed the pharmacokinetics, immunogenicity and safety of Hyrimoz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters. A Phase III confirmatory safety and efficacy study demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic. No meaningful clinical differences were observed.
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