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

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.

Keywords: Similar biological medicinal product, biosimilar, recombinant proteins, quality, biosimilar comparability exercise, biosimilarity, reference medicinal product

Current effective version

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

Reference Number: EMA/CHMP/BWP/247713/2012 Legal effective date: 01/12/2014 Summary:

This guideline replaces 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (EMEA/CHMP/BWP/49348/2005)’

Document history - Revision 1 (current version)

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

Reference Number: EMA/CHMP/BWP/247713/2012 Legal effective date: 01/12/2014 Summary:

This guideline replaces 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (EMEA/CHMP/BWP/49348/2005)’

Overview of comments received on 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance (revision 1)'

Reference Number: EMA/559452/2013 Legal effective date: 01/12/2014

Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

Draft: consultation closed Consultation dates: 31/05/2012 to 30/11/2012 Reference Number: EMA/CHMP/BWP/247713/2012 Summary:

This guideline lays down the quality requirements for a biological medicinal product claiming to be similar to another one already marketed. It addresses the requirements regarding manufacturing processes, the comparability exercise for quality, considering the choice of reference medicinal product, analytical methods, physicochemical characterisation, biological activity, purity and quality attributes for relevant specifications of the similar biological medicinal product.

Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

Draft: consultation closed Consultation dates: 07/02/2011 to 31/05/2011 Reference Number: EMA/CHMP/BWP/617111/2010

Document history - First version

Guideline on similar biological medicinal products containing Biotechnology-derived proteins as active substance: Quality issues

Adopted Reference Number: EMEA/CHMP/BWP/49348/2005 Legal effective date: 01/06/2006