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Celltrion's Actemra biosimilar gets FDA approval

Published: 31 Jan. 2025, 14:58

LEE JAE-LIM
[email protected]

Celltrion logo [CELLTRION]

Celltrion’s biosimilar Avtozma was approved for U.S. market release by the U.S. Food and Drug Administration, the Korean drugmaker said on Friday.

Avtozma, referencing Actemra, is a treatment for inflammatory diseases such as rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and Covid-19.

The drug will be available in both intravenous and subcutaneous injections, with the same formulation and dosages as the reference product.

Actemra is an interleukin-6 (IL-6) inhibitor that reduces inflammation by blocking the IL-6 protein, which is involved in the body’s inflammatory response. Global sales of the drug recorded 2.63 billion Swiss francs ($2.9 billion) in 2023, with the U.S. market share taking up more than half of the total with $1.64 billion.

"This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and health care providers,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, in a statement. “Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs."

BY LEE JAE-LIM [[email protected]]