Celltrion Obtains Approval to Sell Humira Biosimilar 'Yuflyma' in Japan

Approval in Japan Following the US and Europe
Indications for Rheumatoid Arthritis, Inflammatory Bowel Disease, and Psoriasis

Celltrion announced on the 26th that it had obtained marketing approval from the Japanese Ministry of Health, Labour and Welfare for the Humira (active ingredient adalimumab) biosimilar 'Yuflyma' (CT-P17) on the 25th.

Celltrion's Humira biosimilar 'Yuflyma'.
[Photo by Celltrion]

Celltrion received marketing approval for Yuflyma in Japan for the major indications held by the original drug Humira, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS). With this, Yuflyma has obtained marketing approval in a total of 47 countries, including Japan, the United States, and Europe.

With this approval, Celltrion has secured approval for a total of four products in Japan: the breast and stomach cancer treatment 'Herzuma,' the metastatic colorectal cancer treatment 'Vegzelma,' the autoimmune disease treatment 'Remsima,' and Yuflyma, further strengthening its influence and competitiveness in the market. The Japanese market ranks as the third largest global pharmaceutical market.

With the approval of Yuflyma, Celltrion has built an autoimmune disease treatment portfolio in Japan alongside Remsima, which was previously launched. In the oncology antibody treatment market, Celltrion has also entered the Japanese market with Herzuma. As of the first quarter, Herzuma and Remsima recorded market shares of approximately 61% and 27%, respectively.

Celltrion expects that with this approval, Yuflyma will be able to continue the market position established by Herzuma and Remsima in Japan, a major global market. The company plans to analyze the successful cases of these products to quickly establish Yuflyma in the Japanese market.

The Japanese government has recently announced policies to replace about 80% of original biopharmaceuticals with biosimilars and is actively promoting favorable policy support for biosimilars. Celltrion explains that this is expected to lead to additional sales growth through the expansion of its biosimilar portfolio.

The original drug of Yuflyma, Humira, is a blockbuster autoimmune disease treatment sold by AbbVie in the United States. It recorded sales of approximately $21.237 billion (about 27.6081 trillion KRW) last year.

A Celltrion official said, "We expect that Yuflyma will quickly establish itself in the market, just like Herzuma, which has surpassed the original drug and continues to grow in the Japanese market," adding, "We will actively strive to increase our influence in the global adalimumab market by expanding approvals in major countries worldwide."

This content was produced with the assistance of AI translation services.