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Celltrion Applies to Europe for IND to designate Yuflyma

By | translator Choi HeeYoung

22.08.23 10:31:10

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Humira-Yuflyma interchangeable efficacy clinical trial in Europe after the United States



Celltrion announced on the 23rd that it has applied to European regulators for IND to designate Humira biosimilar Yuflyma (CT-17) as an interchangeable similar.

If it is designated as an interchangeable similar, it can be prescribed by replacing the original at a pharmacy without intervention by MD. Celltrion recently submitted IND to the U.S. Food and Drug Administration (FDA) to secure a mutual exchange between Yuflyma and Humira. European clinical trials are conducted on 366 Plaque psoriasis patients in many countries, including Estonia and Poland. It plans to compare and verify pharmacokinetics, efficacy, and safety between the multiple cross-medication group between Yuflyma and Humira and the Humir

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