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