Module 1 Title: Introduction to Biologics and Biosimilars

Module 1 Title: Introduction to Biologics and Biosimilars

Module 1 Title: Introduction to Biologics and Biosimilars

General Practice
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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 Taieb of Universite 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 Joao Gonçalves of Faculty of Pharmacy at University of Lisbon, Portugal, Dr Stemer, Simon Cheesman of University College London Hospitals, United Kingdom, Mr Taieb, and Dirk Arnold of Asklepios Tumorzentrun Hamburg, Germany regarding use of biosimilars in clinical practice.

Topics covered

i. Introduction to biological drugs/biologics

ii. Defining biosimilars

iii. Biosimilars’ manufacturing

iv. Biosimilarity

v. Steps to regulatory approval

vi. Extrapolation principlevii. Regulatory differences between biologics and biosimilars

viii. Complex structure of biological molecules

ix. Biosimilars’ pharmacovigilance

x. Benefits of biosimilars

Learning outcomes

i. Understanding of differences between biologics, biosimilars and small-molecule drugs

ii. Basic comprehension of the biologics’ and biosimilars’ manufacturing process

iii. Learning about biosimilarity

iv. Understanding the differences in regulatory pathways between biologics and biosimilars

v. Learning about biologics’ and biosimilars’ complex structure and clinical implications

vi. Discovering biosimilars’ potential benefits

Sponsored by:

Amgen HK