MIMS Education

Introduction to Biologics and Biosimilars

Introduction to Biologics and Biosimilars

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 1 of Biosimilar Modules for Continued Professional Development comprises three short videos. In the first video, the talk given by presenter Gay Gauvin, Global Operations Director, Biosimilars, Amgen, will provide healthcare professionals with a basic understanding of biological drugs, what differentiates them from small-molecule drugs, as well as the fundamentals of biosimilars development and manufacturing. In the second video, Julien Taïeb of Université Paris Descartes, France and Dr Gunar Stemer of Vienna General Hospital, Austria will talk the viewers through the regulatory pathway for biosimilar approvals. The third video provides insights from João Gonçalves of Faculty of Pharmacy at University of Lisbon, Portugal, Dr Stemer, Simon Cheesman of University College London Hospitals, United Kingdom, Mr Taïeb, and Dirk Arnold of Asklepios Tumorzentrun Hamburg, Germany regarding use of biosimilars in clinical practice.

Topics covered

  • Introduction to biological drugs/biologics
  • Defining biosimilars
  • Biosimilars’ manufacturing
  • Biosimilarity
  • Steps to regulatory approval
  • Extrapolation principle
  • Regulatory differences between biologics and biosimilars
  • Complex structure of biological molecules
  • Biosimilars’ pharmacovigilance
  • Benefits of biosimilars

Learning outcomes

  • Understanding of differences between biologics, biosimilars and small-molecule drugs
  • Basic comprehension of the biologics’ and biosimilars’ manufacturing process
  • Learning about biosimilarity
  • Understanding the differences in regulatory pathways between biologics and biosimilars
  • Learning about biologics’ and biosimilars’ complex structure and clinical implications
  • Discovering biosimilars’ potential benefits

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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