Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use - Scientific guideline

This document addresses issues relating to the unwanted immunogenicity of monoclonal antibodies intended for clinical use. It is intended as an addendum to the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins.

Keywords: Immunogenicity, monoclonal antibodies, similar biological medicinal products, clinical use, assay strategy

Current effective version

Guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use

Adopted Reference Number: EMA/CHMP/BMWP/86289/2010

Document history - First version (current)

Guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use

Adopted Reference Number: EMA/CHMP/BMWP/86289/2010

Overview of comments received on 'guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use' (EMA/CHMP/BMWP/86289/2010)

Reference Number: EMA/420188/2011

Draft guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use

Draft: consultation closed Consultation dates: 18/11/2010 to 31/05/2011 Reference Number: EMA/CHMP/BMWP/86289/2010

Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use.

Draft: consultation closed Reference Number: EMEA/CHMP/BMWP/114720/2009