Celltrion Inc. secured Japanese approval for Avtozma, the first biosimilar of Roche’s autoimmune drug Actemra in the country, bolstering the South Korean biosimilar giant’s growing presence in one of the world’s most competitive biologics markets.
Japan’s Ministry of Health, Labor and Welfare cleared Avtozma for use in treating autoimmune diseases such as rheumatoid arthritis, Castleman’s disease, systemic juvenile idiopathic arthritis and cytokine release syndrome, the company said Monday.
The drug, which contains the active ingredient tocilizumab, is an interleukin-6 receptor antagonist used as an immunosuppressant.
The reference product, Actemra, generated about 4 trillion won ($312 million) in global sales in 2024, with Japan’s tocilizumab market valued at roughly 440 billion won.
Celltrion has rapidly gained share in Japan with other biosimilars.
Remsima, its copy of J&J’s Remicade, controls the largest 41% of the local autoimmune disease therapy market, according to IQVIA.
Yuflyma, a Humira alternative, expanded its share to 12% from 8% in four months.
Herzuma, for early-stage breast cancer, holds 75%, while Vegzelma, used for metastatic colorectal cancer, has 29%.
The approval comes as Japan’s biosimilar market grows at a compound annual rate of more than 10%.
Avtozma was cleared earlier this year by both the US Food and Drug Administration and the European Commission.
By Dae-Kyu Ahn
powerzanic@hankyung.com
Sookyung Seo edited this article.
