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

> Protein biology and biologic medications

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
Coming soon
> Biologic and biosimilar manufacture

CHAPTER 2

Biologic and biosimilar manufacture

Covering development and manufacture of a biologic or biosimilar, inherent variability and quality management
Coming soon
> Biologic product stability – background theory

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
Coming soon
> Interpretation of stability data

CHAPTER 4

Interpretation of stability data

Describing factors to consider for interpretation of stability and the associated data
Coming soon
> Excipients

CHAPTER 5

Excipients

Including reasons for use and classification of excipients and how they maintain biologic or biosimilar stability and integrity
Coming soon
> Approving a biosimilar

CHAPTER 6

Approving a biosimilar

Summarising the regulatory principles underlying biosimilar approval and how this differs from the reference biopharmaceutical and small molecule generics
Coming soon
> Immunogenicity

CHAPTER 7

Immunogenicity

Discussing factors effecting immunogenicity and resultant safety and efficacy of a biopharmaceutical
Coming soon
> Pharmacovigilance

Chapter 8

Pharmacovigilance

Evaluating why pharmacovigilance is essential to characterise the safety and efficacy of biopharmaceuticals and biosimilars
Coming soon
> Biosimilars in practice

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
Coming soon
> Patient considerations and communication

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
Coming soon