Sandoz, a Novartis division has 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 EC approval was based on review of a comprehensive development program, which confirmed Zessly matched its reference medicine in terms of safety, efficacy and quality. The clinical Phase III confirmatory study in rheumatoid arthritis met its primary endpoint, demonstrating equivalent efficacy of Zessly to the reference medicine as measured by the American College of Rheumatology 20 response at Week 14.
Zessly is the sixth approved biosimilar medicine for Sandoz, with several more major oncology and immunology launches expected globally by 2020.
Richard Francis, CEO, Sandoz said, “The European Commission approval for Zessly is a key milestone in bringing this important medicine to appropriate patients. 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.”