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Korea’s Celltrion Move For Remsima Bridging Trial In Germany Seen As Flight Path To U.S. 2014 Filing

This article was originally published in PharmAsia News

Executive Summary

South Korea’s Celltrion has received a nod from Germany’s Paul Ehrlich Institut for a bridging study of the Remsima biosimilar of Johnson & Johnson’s tumor necrosis factor inhibitor Remicade (infliximab), a step crucial to hopes of filing for approval in the United States in early 2014.



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