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

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/BWP/247713/2012
Effective from01/12/2014
KeywordsSimilar biological medicinal product, biosimilar, recombinant proteins, quality, biosimilar comparability exercise, biosimilarity, reference medicinal product
DescriptionThis 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

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/12/2014–present

Published: 03/06/2014

Published: 31/05/2012

Published: 22/02/2011

First versionAdopted guidelineIn operation: 01/06/2006–30/11/2014

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