Celltrion Secures Japanese Approval for Autoimmune Disease Treatment 'AVTOZMA'

AVTOZMA Secures Approval in Japan
Following Authorizations in Korea, the US, and Europe

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

With this approval, Celltrion has secured authorization for key indications covered by the original drug, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (CD), and cytokine release syndrome (CRS).

AVTOZMA is an interleukin (IL) inhibitor that reduces inflammation by blocking the action of interleukin-6 (IL-6), which is involved in triggering inflammation in the body. Last year, it recorded global sales of approximately 2.645 billion Swiss francs (about 4 trillion won). According to pharmaceutical market research firm IQVIA, the Japanese tocilizumab market was estimated at about 316 million US dollars (about 440 billion won) as of last year.

The company plans to quickly launch AVTOZMA as a 'first-mover' biosimilar in Japan, which is considered one of the major global pharmaceutical markets, to provide patients with affordable treatment options and to rapidly expand its market share.

Celltrion has already achieved significant results and expanded its influence in Japan's autoimmune disease and oncology markets. Its flagship product, Remsima (ingredient: infliximab), held the top spot in biosimilar prescriptions with a 41% market share as of April this year. Yuflyma (ingredient: adalimumab) also showed rapid growth, increasing from an 8% to a 12% market share in just four months during the same period, a more than 1.5-fold increase.

In the oncology sector, breast and gastric cancer treatment Herzuma (ingredient: trastuzumab) and targeted cancer therapy Vegzelma (ingredient: bevacizumab), used for metastatic colorectal cancer and non-small cell lung cancer, have solidified their presence in the Japanese oncology market. According to IQVIA and local market data, Herzuma held a 75% market share in Japan as of April this year, while Vegzelma, launched in 2023, recorded a 29% market share as of April.

A Celltrion representative stated, "It is especially meaningful that AVTOZMA has become the first tocilizumab biosimilar to receive product approval in Japan, a major global pharmaceutical market," and added, "We will do our utmost to provide patients with stable and affordable treatment options and to strengthen our position in Japan's autoimmune disease treatment market."