Celltrion's Avtozma receives FDA approval for pediatric COVID-19

Celltrion has announced that the U.S. Food and Drug Administration (FDA) has granted additional approval for the intravenous (IV) formulation of its tocilizumab biosimilar, Avtozma, to treat COVID-19 in pediatric patients aged 2 and older.

This expansion moves the treatment scope from adults to include children and adolescents, providing a clinical alternative for high-risk and severely ill pediatric patients who previously had fewer approved treatment options. Avtozma works by inhibiting interleukin (IL)-6 to reduce inflammatory responses.

In the United States, Avtozma already holds approvals for various conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. The IV formulation, which launched in the U.S. last October, is supplied at a wholesale price approximately 35% lower than the original drug, Actemra.

Celltrion has also secured placement on the preferred drug lists of major U.S. pharmacy benefit managers (PBMs), including Express Scripts, CVS Caremark, and Optum, ensuring significant insurance coverage for patients.