Sandoz, a division of Novartis, has received marketing authorization from the European Commission for its biosimilar Hyrimoz (adalimumab) for use in all of the same indications, it was reported yesterday.

This is the fourth Sandoz biosimilar approved in Europe in the past 18 months, and seventh in total. The product is an inhibitor of tumour necrosis factor, a protein that is overproduced in various autoimmune conditions, including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis-causing inflammation and tissue destruction in joints, mucosa or skin.

The company has received approval based on a comprehensive data package, which included analytical, preclinical and clinical research that demonstrated that the product matches the reference biologic in terms of safety, efficacy and technical quality. A randomised, double-blind, three-arm and parallel study proved the pharmacokinetics, immunogenicity and safety of the product. The study achieved the primary endpoint, indicating bioequivalence for all primary pharmacokinetic parameters.