Celltrion Obtains Domestic Approval from MFDS for Humira Biosimilar 'Yuflyma'
[Asia Economy Reporter Gong Byung-sun] Celltrion announced on the 15th that its biosimilar 'Yuflyma,' developed as the first high-concentration formulation biosimilar of Humira by removing citrate, has obtained domestic product approval from the Ministry of Food and Drug Safety.
Specifically, Yuflyma is indicated for adult rheumatoid arthritis, ankylosing spondylitis, adult Crohn's disease, psoriasis, as well as pediatric Crohn's disease, juvenile idiopathic arthritis, and pediatric plaque psoriasis.
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Going forward, Celltrion stated that based on the secured clinical data, it plans to apply for approvals in each country through continuous discussions with global regulatory agencies.
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