Celltrion announced on the 22nd that its biosimilar product 'AVTOZMA' (ingredient name: tocilizumab), a treatment for autoimmune diseases, has received product approval from Japan's Ministry of Health, Labour and Welfare.

Through this approval, AVTOZMA has been authorized for major indications held by the original drug, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman's disease (CD), and cytokine release syndrome (CRS).

AVTOZMA works by inhibiting the action of interleukin (IL)-6, which is involved in causing inflammation in the body, thereby reducing inflammation. It is a type of interleukin (IL) inhibitor. The global sales of the original product, Actemra, were approximately KRW 4 trillion last year. According to pharmaceutical market research firm IQVIA, the tocilizumab market in Japan is estimated to be around KRW 440 billion.

In the Japanese market, Celltrion's AVTOZMA is progressing smoothly as a 'first mover' likely to be launched first. It is expected to provide a new treatment option to patients more quickly than competitors at a more reasonable price than the original product. Celltrion plans to rapidly expand its market share in Japan by leveraging AVTOZMA's first-mover status. In particular, Celltrion is strengthening its influence by achieving significant results in the autoimmune disease and oncology markets in Japan. Its flagship product, Remsima (infliximab), recorded a 41% market share as of April this year and ranked first in prescriptions among biosimilars. Yuflyma (adalimumab) showed rapid growth with a 12% market share during this period.

In the oncology field, breast and gastric cancer treatment Herzuma (trastuzumab) and metastatic colorectal cancer and non-small cell lung cancer targeted therapy Vegzelma (bevacizumab) are dominating the Japanese oncology market. Herzuma has recorded a market share of 75%, while Vegzelma's market share stands at 29%.

A Celltrion representative stated, "With this product approval, AVTOZMA is progressing smoothly as a first mover in Japan, a major market," adding, "We will do our best to provide patients with economical treatment options stably and expand our presence in the local autoimmune disease treatment market."

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