Japanese regulator OKs Celltrion's Humira biosimilar

Korea Biomedical Review

26 September 2023 - Celltrion said it has received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for Yuflyma, a biosimilar referencing Humira (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 US, and EU.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , Biosimilar , Japan