Celltrion Inc. secured Japanese regulatory clearance for Avtozma, becoming the first company to challenge Roche Holding AG’s autoimmune blockbuster Actemra with a biosimilar in Japan’s lucrative pharmaceutical market.
Japan’s Ministry of Health, Labor and Welfare approved the tocilizumab biosimilar for treating rheumatoid arthritis, Castleman disease, juvenile idiopathic arthritis and cytokine release syndrome. The decision follows Celltrion’s January US approval, positioning the South Korean firm to capture market share from Roche’s CHF 1.3 billion ($1.4 billion) global Actemra franchise.
Celltrion already dominates Japan’s biosimilar landscape with its cancer treatments Herzuma commanding 75% market share and Vegzelma securing 29% since launching in 2023. The company’s autoimmune biosimilar Remsima leads with 41% market share.
Japan’s biosimilar market is projected to double to $1.1 billion by 2033, driven by government cost-containment policies that incentivize cheaper alternatives to expensive biologics. The country’s bundled payment system allows hospitals to retain savings from prescribing lower-cost biosimilars.
However, Roche has already absorbed the impact of biosimilar competition on Actemra sales in Europe, suggesting established players are adapting to pricing pressure. Celltrion faces intensifying competition as two other tocilizumab biosimilars already compete in the US market.
The approval reinforces Celltrion’s strategy of targeting high-value biologics in major markets, though success will depend on pricing and physician adoption in Japan’s relationship-driven healthcare system.
