Celltrion announced on October 7 that the U.S. Food and Drug Administration (FDA) has approved an expanded pediatric indication for the intravenous (IV) formulation of Avtozma (tocilizumab), a biosimilar to the autoimmune treatment Actemra. The decision clears the therapy for coronavirus disease 2019 (COVID-19) in hospitalized pediatric patients ages 2 and older.
The regulatory clearance expands Avtozma’s COVID-19 treatment population beyond adults, providing a critical new option for high-risk pediatric and adolescent patients suffering from severe illness. Pediatric populations have historically faced a narrower range of approved therapeutic options compared to adults. As a tocilizumab biosimilar, Avtozma works by inhibiting interleukin-6 (IL-6)—a key pro-inflammatory cytokine—thereby dampening dangerous inflammatory cascades in the body. In the United States, Avtozma is approved across several conditions, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), cytokine release syndrome (CRS), and COVID-19.
Commercial Reach and U.S. Market Impact
Celltrion initially secured FDA approval for both the subcutaneous (SC) and intravenous (IV) formulations of Avtozma in January of last year. Following subsequent approvals for cytokine release syndrome, the latest pediatric COVID-19 label expansion further extends the clinical scope of the hospital-administered IV formulation. Launched in the U.S. market in October of last year, Avtozma IV is offered at a wholesale acquisition cost approximately 35% lower than that of the reference drug, Actemra. The product has also secured preferred status on the commercial formularies of the three largest U.S. pharmacy benefit managers (PBMs)—Express Scripts, CVS Caremark, and Optum—ensuring rebate coverage for more than half of insured American patients.
The reference drug, Actemra, remains a global blockbuster, recording sales of approximately 2.47 billion Swiss francs (around 3.7 trillion KRW) last year. According to data from pharmaceutical market research firm IQVIA, the U.S. market for tocilizumab reached approximately $1.978 billion (around 2.7692 trillion KRW) last year.
"This additional pediatric COVID-19 indication represents a public health achievement that helps fill a critical care gap for younger patients," a Celltrion official said. "It also presents an opportunity to further demonstrate our product's competitiveness across the entire U.S. tocilizumab market."
