Novartis Gets Approval for Remicade Biosimilar in Europe
Novartis NVS announced that its generic arm, Sandoz, obtained approval for Zessly, a biosimilar version of Johnson & Johnson JNJ ’s Remicade, in Europe. Zessly is approved for use in all indications of the branded drug 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 approval from the European Commission is based on review of a comprehensive development program, including analytical, preclinical and clinical data, which confirmed Zessly matching Remicade in terms of safety, efficacy and quality […]