Celltrion announced on August 7 that its intravenous (IV) formulation of the immuno-oncology drug Avtozma (generic name: Tocilizumab) has received additional approval from the U.S. Food and Drug Administration (FDA) for the treatment of cytokine release syndrome (CRS).
CRS is a severe systemic inflammatory response that can occur during treatments such as CAR-T cell therapy. It results from excessive immune activation, leading to a rapid increase in cytokine levels in the blood. This new approval applies exclusively to the IV formulation of Avtozma, which was previously authorized for other indications.
In January of this year, Celltrion received FDA approval for both the subcutaneous (SC) and IV formulations of Avtozma. The recent expansion to include CRS as an approved indication for the IV formulation brings Avtozma in line with the original medicine, which already had approvals for rheumatoid arthritis (RA), giant cell arteritis (GCA), juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), COVID-19, and now CRS in the U.S.
Avtozma, the original product from Celltrion, is an interleukin (IL)-6 inhibitor that reduces inflammation by blocking IL-6 protein involved in inflammatory processes. Last year, it recorded approximately 2.64 billion Swiss francs (roughly 4.5 trillion KRW) in global sales, with over half—about $1.86 billion (roughly 2.6 trillion KRW)—coming from the U.S. market alone.
Following its approval for domestic use in Korea at the end of last year, Celltrion has been accelerating its global market strategy, gaining approvals in the U.S. and Europe earlier this year. The company plans to build a more robust product lineup in the rapidly growing autoimmune disease sector and expand therapeutic areas into bone and eye diseases, further strengthening its presence in key markets such as Europe and the U.S.
A Celltrion spokesperson stated, “With this new approval allowing Avtozma IV to be prescribed for all indications in the U.S., we expect to see increased product competitiveness and market share. As we prepare for the full-scale launch of Avtozma in major markets including the U.S. in the second half of the year, we will carefully analyze market characteristics to ensure rapid product adoption.”
