Immunogenicity assessment of biotechnology-derived therapeutic proteins - Scientific guideline
This document is a revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (EMEA/CHMP/BMWP/14327/2006) on the basis of experience from marketing authorisation applications, scientific advices, and other new information. It includes, among others, more specific guidance for assays for immunogenicity, and integrated analysis of the clinical significance of immunogenicity. The risk of immunogenicity varies between products and product categories, on one hand, and between individuals and patient groups, on the other hand. In order to facilitate the risk assessment, the guideline contains a list of issues to be considered, a multidisciplinary summary of immunogenicity, including risk assessment that should be included in the marketing authorization application.
Keywords: Immunogenicity, therapeutic proteins, anti-drug antibodies (ADA), assays, assay strategy, binding antibodies, neutralising antibodies, risk factors, safety, efficacy, pharmacokinetics, risk management, integrated summary of immunogenicity
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Guideline on immunogenicity assessment of therapeutic proteins - Revision 1 (PDF/263.08 KB)
Adopted
First published: 01/06/2017
Last updated: 01/06/2017
Legal effective date: 01/12/2017
EMEA/CHMP/BMWP/14327/2006 Rev 1 -
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Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins - Revision 1 (PDF/277.58 KB)
Draft: consultation closed
First published: 01/10/2015
Last updated: 01/10/2015
Consultation dates: 01/10/2015 to 31/01/2016
EMEA/CHMP/BMWP/14327/2006 Rev. 1 -
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Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins - Revision 1 (PDF/88.07 KB)
Draft: consultation closed
First published: 25/03/2014
Last updated: 25/03/2014
Consultation dates: 25/03/2014 to 30/06/2014
EMA/275542/2013
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Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins - First version (PDF/167.27 KB)
Adopted
First published: 13/12/2007
Last updated: 13/12/2007
Legal effective date: 01/04/2008
EMEA/CHMP/BMWP/14327/2006 -
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Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins - First version (PDF/162.06 KB)
Draft: consultation closed
First published: 24/01/2007
Last updated: 24/01/2007
EMEA/CHMP/BMWP/14327/2006 -
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Concept paper on guideline on immunogenicity assessment of therapeutic proteins - First version (PDF/78.33 KB)
Draft: consultation closed
First published: 22/02/2006
Last updated: 22/02/2006
EMEA/CHMP/BMWP/246511/2005