The European Medicines Agency ("EMA") has published its revised overarching guideline on biosimilars. The most significant change in the new guidance is that it allows drug developers to use a comparator drug that was authorized outside the European Economic Area ("EEA") in its clinical investigation of a biosimilar. The effective date of the revised guideline is April 30, 2015. Applicants may, however, apply some or all provisions of this guideline beginning October 29, 2014.
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