On January 31, 2025, Celltrion announced that the FDA approved its tocilizumab biosimilar, AVTOZMA® (tocilizumab-anoh), referencing Genentech’s ACTEMRA®. Tocilizumab is a monoclonal antibody that can act as an interleukin-6 (IL-6) inhibitor to reduce inflammation in the body. The FDA approved AVTOZMA® for subcutaneous injection or intravenous infusion for treatment of multiple diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and the coronavirus disease (COVID-19). Celltrion is the third company to receive FDA approval for a tocilizumab biosimilar, joining Fresenius Kabi and Biogen.
AVTOZMA® is Celltrion’s seventh biosimilar to obtain marketing authorization in the United States.
Stay tuned to Big Molecule Watch for more regulatory updates on biosimilars.
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