1. Introduction to Biosimilars

2. Overview

3. What Is a Biosimilar?

4. History of Biosimilar Development

5. Approval of Biosimilars: What Is Needed?

6. What Is a Biological Medicinal Product?

7. Regulatory Approval Process for Non-Biological (ie, "Small Molecule") Generics

8. Regulatory Approval Process for Biosimilars

9. Biosimilars Are Systematically Developed to Match the Reference Product

10. Comparability Exercise: Same Principles in 2 Different Scenarios

11. Comparability Exercise: Scenario 1

12. Manufacturing Changes to Originator Biologics

13. Biological Products Are Inherently Variable

14. Comparability Exercise: Scenario 2

15. Similarity Assessment of a Monoclonal Antibody: Typical Quality Attributes to Be Evaluated

16. Basic Principles for Clinical Development of Biosimilars

17. Key Principles for Extrapolation of Indication

18. Totality of Evidence

19. Biosimilars Are Highly Regulated

20. EU Approvals to Date

21. Ongoing Biosimilar Marketing Authorization Applications in EU

22. Key Definitions

23. Are EU-Approved Biosimilars Interchangeable?

24. Considerations on Interchangeability

25. Biologics: Prices Over Time

26. Impact of Competition on Price

27. Search: What You Need to Know About Biosimilar Medicinal Products

28. Summary

29. Abbreviations

30. Abbreviations (cont)