Real world evidence: Abstract library

Summaries of the latest published papers, data and real-world evidence

Core handbook

Includes chapters on stability, immunogenicity, pharmacovigilance and biosimilars in clinical practice

Expert webinars

Watch experts discuss using biosimilars with real-world cases

Real world evidence: Case studies

A series of regional case studies reflecting on the adoption of biosimilars within different healthcare systems

Resource libraries

A selection of evidence-based and peer-reviewed literature with summaries of key guidance of biosimilar use

Learning chapters

Enhance your learnings on the use of biosimilars and test your knowledge with our mini-quizzes

Learning objectives

After participating in these educational activities, learners will be able to describe:

  • The latest published evidence and supporting data in terms of biosimilar Implementation, Switching and Health economics
  • The biosimilars adoption landscape for Europe, Canada, Australia, the US, the UK and globally
  • Patient considerations and communication when implementing a biosimilar switching programme
  • The general background to biosimilar medications from manufacturing to immunogenicity
  • Considerations relating to product stability and degradation
  • Local regulatory agency guidance In relation to approval and use of biosimilar medications

Learning chapters

> Protein biology and biologic medications


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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> Biologic and biosimilar manufacture


Biologic and biosimilar manufacture

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


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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> Interpretation of stability data


Interpretation of stability data

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



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


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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> Immunogenicity



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

Chapter 8


Evaluating why pharmacovigilance is essential to characterise the safety and efficacy of biopharmaceuticals and biosimilars
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> 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
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> 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
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