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Focus on Regulation

Tag Archives: clinical studies

EMA permits the use of a comparator product authorised outside the EEA in clinical studies for biosimilars

The European Medicines Agency’s (“EMA”) revised overarching guideline on biosimilars (“Guideline”), which was published on 23 October 2014, will come into force on 30 April 2015. The purpose of this Guideline is to describe the concept of biosimilars and to outline the general principles to be applied when generating evidence substantiating the similar nature, in