Sandoz receives European Commission approval for Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases

European Commission's (EC) approval based on comprehensive data package confirming that Zessly matches safety, efficacy and quality of reference medicine. Biosimilars such as Zessly enable earlier patient access to important medicines and positively impact healthcare systems Zessly is the third EC approval for a Sandoz biosimilar in 12 months Holzkirchen, Germany, May 24, 2018 - Sandoz, a Novartis division and the global leader in biosimilars, today announced that the European Commission (EC) has approved Zessly (infliximab) for use in Europe. Zessly is approved for use in all indications of the reference medicine*** including rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. "The European Commission approval for Zessly is a key milestone in bringing this important medicine to appropriate patients," said Richard Francis, CEO, Sandoz. "Biosimilars, such as Zessly, help to address a significant unmet need for earlier patient access to biologic medicines and are at the heart of our Sandoz commitment to improving and extending lives." The EC approval was based on review of a comprehensive development program, including analytical, preclinical and clinical data, which confirmed Zessly matched its reference medicine in terms of safety, efficacy and quality. The clinical Phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02) met its primary endpoint, demonstrating equivalent efficacy of Zessly to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.