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 authorisation of a proposed biosimilar adalimumab.

The CHMP opinion recommends the proposed Sandoz biosimilar adalimumab for treatment of all indications of its reference medicine including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.

"The positive CHMP opinion for our biosimilar adalimumab is an important milestone for the millions of patients looking to reclaim their health after an autoimmune disease diagnosis," said Richard Francis, CEO, Sandoz. "If approved by the European Commission, the introduction of our biosimilar adalimumab can help to expand access for those who need it most and give patients and doctors confidence in their chosen treatment option. Biosimilar adalimumab is backed by robust science, assured by manufacturing excellence and created with a deep understanding of customer needs."

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 randomised, 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).

The European Commission (EC) takes binding decisions on the authorisation 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 centralised marketing authorisation 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.

In some cases of autoimmune disease, the immune system damages the body's own tissues. Adalimumab can be a potentially appropriate treatment option for certain patients across a variety of indications. Overproduction of the protein tumor necrosis factor (TNF) happens as a result of inflammatory and immunological conditions such as rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis. It can cause inflammation and destruction of tissues in the joints, mucosa or skin. Adalimumab works by targeting and blocking the protein that contributes to disease symptoms.