Sandoz said Friday 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.
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 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