Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference number CHMP/BWP/247713/2012
Published 03/06/2014
Effective from 01/12/2014
Keywords Similar biological medicinal product, biosimilar, recombinant proteins, quality, biosimilar comparability exercise, biosimilarity, reference medicinal product
Description This document outlines the quality requirements for a biological medicinal product claiming to be similar to another one already marketed. It covers manufacturing processes, the comparability exercise for quality, considering the choice of reference product, analytical methods, physicochemical characterisation, biological activity, purity and specifications of the similar biological medicinal product.

Document history

Revision 1

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


Draft guideline


PDF iconConcept paper

In operation: 01/12/2014–present


Published: 03/06/2014


Published: 31/05/2012


Published: 22/02/2011

First version PDF iconAdopted guideline In operation: 01/06/2006–30/11/2014

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