Curriculum overview
Stay abreast of your knowledge of biosimilars used for the treatment of solid tumours
Core handbook
Includes chapters on stability, immunogenicity, pharmacovigilance and biosimilars in clinical practice
Learning chapters
Enhance your learnings on the use of biosimilars and test your knowledge with our mini-quizzes
Expert webinars
Watch experts discuss using biosimilars with real-world cases
Resource library
A selection of evidence-based and peer-reviewed literature with summaries of key guidance of biosimilar use
Learning objectives
After participating in these educational activities, learners will be able to describe:
- The different stages associated with the biosimilar manufacturing process
- The structural features of biosimilars including primary, secondary, tertiary, and quaternary, as well as post-translational modifications
- Processes and formation of anti-drug antibodies and immunogenicity concerns
- Classification of excipients/inactive ingredients, why they are used, and how they maintain product integrity and stability
- Changes in formulation depending on route of administration
- Types of stability, degradation, factors affecting stability, and study/trial design
- Interpretation of stability data, evaluation of risks Vs benefits, SPC wording surrounding stability
- Pharmacovigilance monitoring processes and how the data is established
- Local regulatory agency guidance in relation bioequivalence studies
- Patient switch conversation structure and communication points