Module 1 - Introduction to Biologics and Biosimilars

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

Module 2 - Biosimilarity, Extrapolation and Immunogenicity

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

Module 3 - Selecting and Prescribing a Biosimilar

About this course

Module 3 of Biosimilar Modules for Continued Professional Development comprises three videos. Dr. Gunar Stemer of Vienna General Hospital, Austria, Professor Irene Krämer of Medical Center of the Johannes Gutenberg-University, Mainz, Germany, Dr. Niels Boone of Zuyderland Medisch Centrum, Maastricht, The Netherlands, Julien Taïeb of Université Paris Descartes, France, Dirk Arnold of Asklepios Tumorzentrun Hamburg, Germany, and Simon Cheesman of University College London Hospitals, United Kingdom discuss what pharmacists need to consider when prescribing a biosimilar, the importance of educating all stakeholders with regards to biosimilar agents and challenges of biosimilars’ pharmacovigilance.

Topics covered

• What pharmacists should consider when prescribing a biosimilar
• Reliability of supply
• Drug-related selection criteria
• Patient-related selection criteria
• Inter-batch variability of biologics and biosimilars
• Challenges in extrapolating efficacy and risks between populations
• Post-marketing surveillance
• List of criteria necessary for European Medicines Agency approval
• Selection matrix tool
• Challenges in biosimilar selection and use
• Pharmacovigilance
• Education of physicians, pharmacists, nurses and patients on biosimilars

Learning outcomes

• Considerations when prescribing a biosimilar
• Appreciating the role of hospital pharmacists when selecting a biosimilar
• Acceptance of variability of biologics and biosimilars
• Understanding the differences in originator and biosimilars assessment
• Learning about a selection matrix tool for biosimilars
• Appreciating the importance of pharmacovigilance
• Understanding the importance of educating physicians, pharmacists, nurses, and patients on biosimilars

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