Celltrion Gains Korean Approval For Avtozma, Advancing Autoimmune Treatments

Today, Celltrion announced that Korea's Ministry of Food and Drug Safety approved its biosimilar Avtozma (CT-P47), developed as an alternative to Roche's autoimmune disease treatment Actemra (tocilizumab). The approval is based on data from a global phase 3 clinical trial. It covers all indications of Actemra in Korea, including rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and polyarticular juvenile idiopathic arthritis (pJIA).

Actemra is an interleukin-6 (IL-6) inhibitor that targets inflammation-related proteins. The drug generated approximately $2.94 billion in global sales last year. Celltrion has received a positive opinion for Avtozma from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and has also completed its application for FDA approval.

With this milestone, Celltrion becomes the first company in Korea to secure regulatory approval for a biosimilar version of Actemra. This achievement strengthens its portfolio of interleukin inhibitors, which already includes SteQeyma (CT-P43), an FDA-approved biosimilar of Stelara (ustekinumab).