Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use - Scientific guideline
Table of contents
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
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Guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use (PDF/182.82 KB)
Adopted
First published: 15/06/2012
Last updated: 15/06/2012
EMA/CHMP/BMWP/86289/2010 -
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Overview of comments received on 'guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use' (EMA/CHMP/BMWP/86289/2010) (PDF/784.74 KB)
First published: 15/06/2012
Last updated: 15/06/2012
EMA/420188/2011 -
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Draft guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use (PDF/180.9 KB)
Draft: consultation closed
First published: 26/11/2010
Last updated: 26/11/2010
Consultation dates: 18/11/2010 to 31/05/2011
EMA/CHMP/BMWP/86289/2010 -
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Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. (PDF/38.97 KB)
Draft: consultation closed
First published: 19/03/2009
Last updated: 19/03/2009
EMEA/CHMP/BMWP/114720/2009
- Multidisciplinary: biosimilar
- Directive 2001/83/EC
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Good pharmacovigilance practices (GVP) module V – risk management systems
- Bioanalytical method validation
- Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues
- Development, production, characterisation and specifications for monoclonal antibodies and related products
- ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
- Similar biological medicinal products
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues