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 infliximab, a proposed biosimilar to reference medicine infliximab.
The CHMP opinion recommends the proposed Sandoz biosimilar infliximab for the treatment of all indications of its reference medicine across gastroenterology, rheumatology, and dermatology.
“Sandoz is proud to be at the forefront of diversifying the biologics treatment landscape by bringing biosimilar medicines to market for patients living with devastating autoimmune diseases,” said Richard Francis, CEO, Sandoz. “Today’s positive CHMP opinion marks a strong step forward in our efforts to accelerate patient access to biologics, and specifically infliximab, through our leading portfolio.”
The opinion is based on a comprehensive data package that is expected to confirm the biosimilarity of infliximab to the reference medicine with analytical, preclinical and clinical data matching across quality, efficacy, and safety.
The clinical Phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02) met its primary endpoint, demonstrating the equivalent efficacy of proposed Sandoz biosimilar infliximab to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.
The European Commission (EC) will review the CHMP’s positive opinion. The EC has the authority to approve medicines for the European Union (EU). If approved, the EC will grant a centralized marketing authorization that will be valid in the 28 member countries 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.
As the leader in biosimilars with five marketed products and several more major oncology and immunology launches expected globally by 2020, Sandoz acquired infliximab (PF-06438179) development, commercialization and manufacturing rights from Pfizer in February 2016 for the 28 EU countries plus Norway, Iceland, and Liechtenstein that forms the EEA.
Under the terms of the divestment, Pfizer retains commercialization and manufacturing rights to infliximab (PF-06438179) in countries outside the EEA.
Infliximab blocks the action of the protein tumor necrosis factor (TNF)-alpha in patients with certain autoimmune conditions in which excess TNF-alpha activity may be harmful or cause the onset of disease. By blocking the action of TNF-alpha, infliximab is believed to inhibit an underlying cause of inflammation.