Celltrion announced on the 7th that its intravenous (IV) formulation of AVTOZMA(generic name tocilizumab), a treatment for autoimmune diseases, has received additional approval from the U.S. Food and Drug Administration (FDA) for the indication of cytokine release syndrome (CRS).
AVTOZMAis a biosimilar (a copy of a biological drug) of the original drug Actemra from Swiss pharmaceutical company Roche, which received domestic approval at the end of last year and has since obtained product approvals in the U.S. and Europe earlier this year.
CRS, for which the indication was added this time, is a severe systemic inflammatory response disease that can occur during immune cell therapies such as chimeric antigen receptor (CAR)-T cell treatment. It occurs due to excessive immune activation, causing a rapid increase in cytokine levels in the bloodstream.
With this approval, the AVTOZMAIV formulation has obtained approval for the full label of indications acquired in the U.S., similar to the original drug. It can be used for rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, coronavirus disease, and CRS. The principle is to inhibit the interleukin (IL)-6 protein involved in causing inflammation, thereby reducing inflammation.
Celltrion plans to launch AVTOZMAin markets worldwide, including the U.S., in the second half of this year. A company official noted, "With this approval, the AVTOZMAIV formulation can be prescribed for all indications in the U.S., expanding treatment options and enhancing product competitiveness and market share. We will do our utmost to ensure early establishment of the product in key markets, including the U.S., as we approach the launch of AVTOZMAin the second half of the year."
Meanwhile, Actemra's global sales last year were approximately 2.645 billion Swiss francs (about 4.4965 trillion won), with sales of $1.862 billion (about 2.6068 trillion won) achieved in the U.S. market alone.