Celltrion said it has received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for Yuflyma, a biosimilar referencing Humira (ingredient: adalimumab).

Humira, the original medicine, is prescribed primarily for autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis. With the approval in Japan, Celltrion has won approvals for Yuflyma in 47 countries, including the U.S., and EU.

With this recent authorization, Celltrion stressed that it solidified its presence in the Japanese pharmaceutical market, now boasting four approved products, including Herceptin (breast and stomach cancer), Vegzelma (various solid cancers), and Remsima (autoimmune diseases).

Celltrion has already established a formidable market presence in Japan. As of the first quarter of this year, market shares for Herceptin and Remsima stood at approximately 61 percent and 27 percent, respectively.

Given the precedents set by Herceptin and Remsima, Celltrion has high hopes for Yuflyma to expand its market share in Japan quickly.

Celltrion also expects that the fact that the Japanese government recently announced a proactive initiative, aiming to replace around 80 percent of original biopharmaceuticals with biosimilars, will establish a favorable market environment for biosimilar companies.

"We are optimistic about Yuflyma quickly finding its footing in the Japanese market," a Celltrion official said. "Our objective is to further expand our influence in the global adalimumab market by securing approvals in additional key countries."