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
-
List item
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) (PDF/140.29 KB)
First published: 03/06/2014
Last updated: 03/06/2014
Legal effective date: 01/12/2014
EMA/CHMP/BWP/247713/2012 -
List item
Overview of comments received on 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance (revision 1)' (PDF/677.96 KB)
First published: 03/06/2014
Last updated: 03/06/2014
Legal effective date: 01/12/2014
EMA/559452/2013 -
List item
Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) (PDF/127.69 KB)
Draft: consultation closed
First published: 31/05/2012
Last updated: 31/05/2012
Consultation dates: 31/05/2012 to 30/11/2012
EMA/CHMP/BWP/247713/2012 -
List item
Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (PDF/64.15 KB)
Draft: consultation closed
First published: 22/02/2011
Last updated: 22/02/2011
Consultation dates: 07/02/2011 to 31/05/2011
EMA/CHMP/BWP/617111/2010