CHMP recommends biosimilar adalimumab to treat all indications of the reference product.- Sandoz.

Sandoz, a Novartis division and the global leader in biosimilars, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of a proposed biosimilar adalimumab (GP 2017). The CHMP opinion recommends the proposed Sandoz biosimilar adalimumab for treatment of all indications of its reference medicine, Humira, including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.

The comprehensive data package comprises analytical, preclinical and clinical data, and demonstrates that proposed biosimilar adalimumab matches the reference biologic in terms of safety, efficacy and quality. A randomized, double-blind, three-arm parallel study was conducted to determine the pharmacokinetics, immunogenicity and safety of biosimilar adalimumab. The study met its primary objective in demonstrating PK bioequivalence. Additionally, clinical studies submitted for review include the Phase III confirmatory safety and efficacy study in patients with moderate to severe chronic plaque-type psoriasis (ADACCESS trial).

The European Commission (EC) takes binding decisions on the authorization of medicines valid throughout the EU. It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety and efficacy standards. If approved, the EC will grant a centralized marketing authorization that will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions based on the EC's recommendation.