Posted by Michael Wonder on 23 Mar 2018
Sandoz receives positive CHMP opinion for proposed biosimilar infliximab
23 March 2018 - Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab matches the reference medicine.
Sandoz announced today that the CHMP of the EMA has adopted a positive opinion for marketing authorization of infliximab, a proposed biosimilar to reference medicine infliximab.
The opinion is based on a comprehensive data package which 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.
