Celltrion said Monday it has received marketing authorization from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Avtozma, a biosimilar referencing Roche’s Actemra (ingredient: tocilizumab).

The approval covers the main indications held by the original drug, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman’s disease (CD), and cytokine release syndrome (CRS).

Avtozma is an interleukin-6 (IL-6) inhibitor designed to block the activity of IL-6, a key cytokine that drives inflammation. By suppressing IL-6 signaling, the therapy reduces inflammation and helps manage immune-mediated disorders.

According to IQVIA, Japan’s tocilizumab market was valued at about $316 million in 2024, while global sales of the drug reached 2.6 billion Swiss francs, roughly $3.3 billion.

With Avtozma’s approval, Celltrion aims to launch the first Actemra biosimilar in Japan, offering patients a more affordable treatment option and accelerating its share in the country’s autoimmune disease market.

Celltrion has already built a strong track record in Japan across both autoimmune and oncology segments.

Remsima (ingredient: infliximab), the company’s flagship biosimilar, achieved a 41 percent market share as of April 2025, ranking first among biosimilars prescribed in the country.

Yuflyma (ingredient: adalimumab) has also grown rapidly, expanding from 8 percent market share at the start of the year to 12 percent in just four months.

In oncology, Herzuma (ingredient: trastuzumab) has firmly dominated the Japanese breast and gastric cancer markets, holding a 75 percent market share as of April.

Vegzelma (ingredient: bevacizumab), launched in 2023, has also gained momentum, capturing 29 percent of the metastatic colorectal and non-small cell lung cancer treatment market by April 2025.

Celltrion said the latest approval highlights its ability to serve patients in highly competitive global markets.

“It is highly meaningful that Avtozma has become the first tocilizumab biosimilar approved in Japan, a key global pharmaceutical market,” a Celltrion official said. “We will do our utmost to provide patients with an affordable and reliable treatment option, while reinforcing our presence in Japan’s autoimmune disease market.”