Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies

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TitleWorkshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies
Date24/10/2011 - 24/10/2011
LocationEuropean Medicines Agency, London, UK
SummaryThe European Medicines Agency workshop on biosimilar monoclonal antibodies is intended to discuss the draft guideline on similar biological medicinal products containing monoclonal antibodies and the guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use with stakeholders who provided comments on the two guidelines during the public consultation phase. Registration closed.

All documents

Name Language First published Last updated
Agenda - Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies (English only) 24/10/2011  
Report - Closed workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies (English only) 15/06/2012  
List of participants: Closed workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies (English only) 15/06/2012  
Presentation - Draft guideline on biosimilar monoclonal antibodies (English only) 15/06/2012  
Presentation - General presentation by stakeholders (English only) 15/06/2012  
Presentation - High-level perspective of the biosimilars industry (English only) 15/06/2012  
Presentation - Session 1: Non-clinical issues: Introduction (English only) 15/06/2012  
Presentation - Session 1.1: Non-clinical issues: Off-target toxicity – does it occur and how should we detect it? (English only) 15/06/2012  
Presentation - Off-target toxicity (English only) 15/06/2012  
Presentation - Off-target toxicity – a regulator's view (English only) 15/06/2012  
Presentation - Session 1.4: Non-clinical issues: Risk-based approach - rationale and decision points (English only) 15/06/2012  
Presentation - Guideline on biosimilar monoclonal antibodies: Non-clinical issues: A risk-based approach - rationale and decision points (English only) 15/06/2012  
Presentation - Regulator's view: A risk-based approach - rationale and decision points (English only) 15/06/2012  
Presentation - Equivalence vs. non-inferiority: Introduction (English only) 15/06/2012  
Presentation - Session 2.1: Clinical issues: Could we accept non-inferiority instead of equivalence trials in specific situations? (English only) 15/06/2012  
Presentation - Biosimilar industry perspective on clinical issues - Equivalence versus non-inferiority (English only) 15/06/2012  
Presentation - Equivalence vs. non-inferiority: Regulator‘s view (English only) 15/06/2012  
Presentation - Session 3.1: Clinical issues: Is product / indication specific guidance necessary and meaningful? (English only) 15/06/2012  
Presentation - Is product / indication specific guidance already necessary and meaningful? (English only) 15/06/2012  
Presentation - Is product / indication specific guidance already necessary and meaningful? (English only) 15/06/2012  
Presentation - How should antibodies against monoclonal antibody therapeutics be assessed? (English only) 15/06/2012  
Presentation - Biosimilar industry perspective on draft guideline on immunogenicity assessment of monoclonal antibodies (English only) 15/06/2012  
Presentation - Session 4.3: Immunogenicity of monoclonal antibodies: Risk-based approach – What are the risk factors? (English only) 15/06/2012  
Presentation - Immunogenicity guideline monoclonal antibodies - A risk-based approach - rationale and decision points (English only) 15/06/2012  
Presentation - Session 5.1: Pharmacovigilance: What data / studies could be deferred to the post-authorisation phase? (English only) 15/06/2012  
Presentation - Pharmacovigilance (English only) 15/06/2012  
Presentation - Pharmacovigilance (English only) 15/06/2012  

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