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European Commission Approves Sandoz’s Remicade Biosimilar
Drugs Submissions and Approvals
The European Commission approved Zessly (infliximab), Sandoz’s Remicade biosimilar for treatment of rheumatological and dermatological disease.
The approval covers all indications of the reference medicine, including adult and pediatric Crohn’s disease, rheumatoid arthritis and adult ulcerative colitis. Zessly is Sandoz’s sixth approved biosimilar.
The Commission based the approval on clinical Phase II confirmatory studies in rheumatoid arthritis.