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)

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

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)

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

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)'

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

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

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

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

Consultation dates: 07/02/2011 to 31/05/2011Draft: consultation closedReference 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

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