Biosimilar guideline revamp allows use of non-EU comparator product
This article was originally published in SRA
Executive Summary
The European Medicines Agency has overhauled its overarching guideline on biosimilars, bringing it up to date and clarifying the principles and terminology of biosimilarity1,2. The revised document says that in some cases a biosimilar could be compared with a reference drug approved outside the EU, and that a biosimilar could exceptionally be authorised on the basis of a pharmacokinetic comparative study without the need for a comparative clinical efficacy study.