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Korea FDA Gears Up To Release Biosimilar Guidelines Modeled After EU Rules

This article was originally published in PharmAsia News

Executive Summary

SEOUL - South Korea's FDA is getting ready to release - possibly by the end of May - an initial version of guidelines for approval and registration of biosimilars modeled after European Union rules. The guidelines will wrap up KFDA's year-long drive to set up a regulatory framework for the new breed of follow-on biologics

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