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EMA's concept paper defines biosimilar regulation problem areas

This article was originally published in Scrip

Executive Summary

It looks as though forthcoming updates to guidelines on developing biosimilar medicines will reflect "current thinking and enhanced learning", if the European Medicines Agency's concept paper on proposed revisions are anything to go by, says Cecil Nick, a consultant for Parexel. The concept paper, put out for consultation on 3 October 2011, address issues including clinical equivalence studies requirements on immunogenicity.



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