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
Learning chapters
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CHAPTER 1
Protein biology and biologic medications
Discussing the fundamentals of protein synthesis - a process that produces some of the most used biologics and their biosimilars
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CHAPTER 2
Biologic and biosimilar manufacture
Covering development and manufacture of a biologic or biosimilar, inherent variability and quality management
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CHAPTER 3
Biologic product stability – background theory
Detailing the types of factors affecting stability and degradation of biologics and biosimilars, and the studies used to measure
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CHAPTER 4
Interpretation of stability data
Describing factors to consider for interpretation of stability and the associated data
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CHAPTER 5
Excipients
Including reasons for use and classification of excipients and how they maintain biologic or biosimilar stability and integrity
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CHAPTER 6
Approving a biosimilar
Summarising the regulatory principles underlying biosimilar approval and how this differs from the reference biopharmaceutical and small molecule generics
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CHAPTER 7
Immunogenicity
Discussing factors effecting immunogenicity and resultant safety and efficacy of a biopharmaceutical
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Chapter 8
Pharmacovigilance
Evaluating why pharmacovigilance is essential to characterise the safety and efficacy of biopharmaceuticals and biosimilars
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Chapter 9
Biosimilars in practice
Detailing what to consider when reviewing a biosimilar for inclusion in a formulary and the role of pharmacists in implementing biosimilars into the health service
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chapter 10
Patient considerations and communication
Discussing the educational needs of patients about biosimilars and the pharmacists’ role in delivering advice and support to patients taking biosimilars
