Immunogenicity assessment of biotechnology-derived therapeutic proteins

Current effective version

PDF iconAdopted guideline - Revision 1

Reference numberEMEA/CHMP/BMWP/14327/2006 Rev.1
Published01/06/2017
Effective from01/12/2017
KeywordsImmunogenicity, therapeutic proteins, anti-drug antibodies (ADA), assays, assay strategy, binding antibodies, neutralising antibodies, risk factors, safety, efficacy, pharmacokinetics, risk management, integrated summary of immunogenicity
DescriptionThis 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.


Document history

Revision 1
Current version

PDF iconAdopted guideline

PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/12/2017-present

Published: 01/10/2015


Published: 25/03/2014

First version

PDF iconAdopted guideline


PDF iconDraft guideline


PDF iconConcept paper

Published: 13/12/2007


Published: 24/01/2007


Published: 22/02/2006


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