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Novartis' Sandoz Gets European Commission Approval For Biosimilar Hyrimoz

Sandoz, a division of Novartis AG (NVS), said that the European Commission or EC granted marketing authorization to biosimilar Hyrimoz, or adalimumab, 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, according to Sandoz.

A Phase III confirmatory safety and efficacy study, ADACCESS, 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.

Rheumatoid arthritis alone affects up to 1 percent of people in the European Union.

Patients with moderate to severe rheumatoid arthritis can have chronic inflammation that causes fatigue, pain and joint stiffness. Symptoms can be reversible with appropriate treatment, however the joint damage and the resulting disability are permanent.

"We believe in making access happen for patients who are suffering from chronic inflammatory diseases. Earlier and expanded access to important, disease-modifying, biologic medicines can fundamentally change how patients manage their health," said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz.

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