South Korean pharmaceutical firm Celltrion announced Monday that Avtozma, a biosimilar of Actemra, has received approval from the European Commission.

The approval covers major indications of the original drug, including rheumatoid arthritis and giant cell arteritis.

Avtozma, an interleukin inhibitor, reduces inflammation by targeting the IL-6 protein. With this approval, Celltrion expands its autoimmune disease treatment portfolio beyond tumor necrosis factor-alpha inhibitors, broadening the scope of treatable patients.

The biosimilar is the last of four product approvals in Europe this month, following Eydenzelt (Eylea biosimilar), Osenbelt and Stovoclo (Prolia-Xgeva biosimilar). These additions complete Celltrion's 11-product portfolio in Europe, a milestone already achieved domestically in December 2024.

Celltrion’s total market value for the 11 products is approximately 150 trillion won ($105.2 billion), covering treatments for autoimmune diseases, cancer, allergies, ophthalmology and bone disorders. The company aims to strengthen its position in the fast-growing autoimmune market while expanding into other therapeutic areas.

"With consecutive product approvals in Europe, one of our key markets, we have successfully achieved our 2025 goal of establishing an 11-product portfolio. This also reaffirms our capabilities in pharmaceutical development,” a Celltrion representative stated. “We will now focus on commercialization to drive global expansion and accelerate growth.”

By Chung Hye-lim (hyelimchung@heraldcorp.com)