Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

  • Email
  • Help

Document details

Download document Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development
Reference number EMA/CHMP/297149/2013 Rev. 1
Status draft: consultation closed
First published 28/06/2013
Last updated 16/01/2014

Summary

In the recent past, several requests submitted for scientific advice contained questions concerning the adequacy of planned inferential statistical approaches to compare quality attributes of a (candidate) biosimilar product to that of a reference medicinal product, or of a particular biological drug compound in versions pre- and post-manufacturing changes. For comparative purposes, several different methodological approaches had been proposed to define comparability (‘acceptance’) ranges as well as ‘similarity’ criteria, mostly based on information on batch-to-batch variability. The reflection paper to be prepared will try to reflect on (the limitations of) comparison techniques proposed in the past, but will also try to come up with alternative approaches for the evaluation of ‘similarity/equivalence’ in quality attributes.