Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies

• Date:
  Monday, 24 October 2011, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The 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.

Documents

Agenda - Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies

Reference Number: EMA/838645/2011

Report - Closed workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies

Reference Number: EMA/97951/2012

List of participants: Closed workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies

Reference Number: EMA/362428/2012

Presentation - Draft guideline on biosimilar monoclonal antibodies

Presentation - General presentation by stakeholders

Presentation - High-level perspective of the biosimilars industry

Presentation - Session 1: Non-clinical issues: Introduction

Presentation - Session 1.1: Non-clinical issues: Off-target toxicity – does it occur and how should we detect it?

Presentation - Off-target toxicity

Presentation - Off-target toxicity – a regulator's view

Presentation - Session 1.4: Non-clinical issues: Risk-based approach - rationale and decision points

Presentation - Guideline on biosimilar monoclonal antibodies: Non-clinical issues: A risk-based approach - rationale and decision points

Presentation - Regulator's view: A risk-based approach - rationale and decision points

Presentation - Equivalence vs. non-inferiority: Introduction

Presentation - Session 2.1: Clinical issues: Could we accept non-inferiority instead of equivalence trials in specific situations?

Presentation - Biosimilar industry perspective on clinical issues - Equivalence versus non-inferiority

Presentation - Equivalence vs. non-inferiority: Regulator‘s view

Presentation - Session 3.1: Clinical issues: Is product / indication specific guidance necessary and meaningful?

Presentation - Is product / indication specific guidance already necessary and meaningful?

Presentation - Is product / indication specific guidance already necessary and meaningful?

Presentation - How should antibodies against monoclonal antibody therapeutics be assessed?

Presentation - Biosimilar industry perspective on draft guideline on immunogenicity assessment of monoclonal antibodies

Presentation - Session 4.3: Immunogenicity of monoclonal antibodies: Risk-based approach – What are the risk factors?

Presentation - Immunogenicity guideline monoclonal antibodies - A risk-based approach - rationale and decision points

Presentation - Session 5.1: Pharmacovigilance: What data / studies could be deferred to the post-authorisation phase?

Presentation - Pharmacovigilance

Presentation - Pharmacovigilance