EU approves biosimilar Zessly, to treat all indications of infliximab, the reference medicine.- Sandoz.
Sandoz, 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 (Remicade) 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, 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.
Comment: Remicade patents expired in the EU in February 2015.
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