Sandoz, a Novartis division and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz (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. 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.
Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. Hyrimoz is the company’s seventh approved biosimilar medicine in Europe. Additional biosimilars for oncology and immunology indications are expected to launch globally across major regions by 2020.
Hyrimoz is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions-including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis-causing inflammation and tissue destruction in joints, mucosa or skin. In some cases of autoimmune disease, the immune system damages the body’s own tissues. Hyrimoz can be a potentially appropriate treatment option for certain patients across a variety of indications. Hyrimoz works by targeting and blocking the protein that contributes to disease symptoms.