MIMS Education

Biosimilarity, Extrapolation and Immunogenicity

Biosimilarity, Extrapolation and Immunogenicity

A badge with ribbon in color black 0.5 Point | An analog clock in color black 2h | A black calendar with white triangle in center that has a black exclamation point in the middle 30 Jun 2021 


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The information contained on this site is intended for Healthcare Professionals only

The materials in this virtual exhibition are approved for use only in Hong Kong. Prescribing information may vary depending on local approval in each country. Therefore, before prescribing any product, always refer to local materials such as the prescribing information and/ or the Summary of Product Characteristics (SmPC).

About this course

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

  • Basis for extrapolation
  • Concept of totality of evidence
  • Key clinical trial features for demonstrating biosimilarity
  • Sensitive endpoint and patient populations
  • Immunogenicity as a feature of all biologics
  • Impact on bioavailability
  • Anti-drug antibodies (ADAs)
  • Sensitivity and specificity of detection assays
  • Clinical impact of immunogenicity
  • Safety of switching to and from biosimilars

Learning outcomes

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

CME Accreditors#:

Hong Kong College of Community Medicine (AP-SS)
Hong Kong College of Radiologists (B-PP)
The College of Surgeons of Hong Kong (CME-PP)

#Please contact respective authorities directly for CME accreditation if it is not listed above

0.5 CME points available

  • A minimum score of 8/10 (80%) in the multiple-choice quiz is required to obtain 0.5 CME points.
  • A certificate can be downloaded upon successful completion.

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