MIMS Education

Module 2: Justifying extrapolation,demonstrating biosimilarity and addressing immunogenicity

Module 2: Justifying extrapolation,demonstrating biosimilarity and addressing immunogenicity

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Module 2 of Biosimilar Modules for Continued Professional Development comprises two videos. In the first video, Dr Richard Markus, Vice President of Biosimilar Global Development at Amgen, talks about scientific justification of indication extrapolation and the optimal trial design for demonstrating biosimilarity. The second talk given by João Gonçalves of Faculty of Pharmacy at University of Lisbon, Portugal, focuses on immunogenicity of biological agents and its clinical impact.

Topics covered

  1. Basis for extrapolation
  2. Concept of totality of evidence
  3. Key clinical trial features for demonstrating biosimilarity
  4. Sensitive endpoint and patient populations
  5. Immunogenicity as a feature of all biologics
  6. Impact on bioavailability
  7. Anti-drug antibodies (ADAs)
  8. Sensitivity and specificity of detection assays
  9. Clinical impact of immunogenicity
  10. Safety of switching to and from biosimilars

Learning outcomes

  1. Understanding the role reference product knowledge and totality of evidence play in justifying extrapolation
  2. Knowing which endpoints would identify meaningful differences between reference product and biosimilar
  3. Learning about immunogenicity and different types of ADAs
  4. Understanding the effect of aggregation and impurity on immunogenicity
  5. Discovering the potential clinical impact of immunogenicity
  6. Being introduced to the concept of transient ADA response
  7. Finding out if there are any safety issues associated with switching to and from biosimilars

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