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

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