Celltrion, Inc. (068270.KS) Wednesday said that the U.S. Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of Avtozma to include the treatment of cytokine release syndrome (CRS) in patients aged 2 years and older.
Earlier this year, the FDA approved Avtozma, a biosimilar to Genentech's Actemra, for several indications including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and coronavirus disease (COVID-19).
Following FDA approval of the additional indication for CRS, Avtozma IV now aligns with all indications approved for Actemra IV in the United States, the company said in a statement.
According to the patent settlement agreement with Genentech, the IV formulation of Avtozma is expected to be available in the U.S. from August 31, 2025.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.