Noticia de Contratación

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 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.

Sandoz has five marketed products and several more major oncology and immunology launches expected globally by 2020, the cpmpany 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 form the EEA. Under the terms of the divestment, Pfizer retains commercialization and manufacturing rights to infliximab (PF-06438179) in countries outside the EEA.