About

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

1. What pharmacists should consider when prescribing a biosimilar
2. Reliability of supply
3. Drug-related selection criteria
4. Patient-related selection criteria
5. Inter-batch variability of biologics and biosimilars
6. Challenges in extrapolating efficacy and risks between populations
7. Post-marketing surveillance
8. List of criteria necessary for European Medicines Agency approval
9. Selection matrix tool
10. Challenges in biosimilar selection and use
11. Pharmacovigilance
12. Education of physicians, pharmacists, nurses and patients on biosimilars

Learning outcomes

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

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