1. Understanding Biologics

3. Biologics and Biosimilars

4. Animation: What Are Biologics?

5. Production of Biologics

6. Sources of Variation in Biologics

7. Variability Is a Natural and Expected Property of All Biologics

8. Glycosylation Affects Protein Properties

9. Most Biologics Have Undergone Manufacturing Changes

10. Trastuzumab Properties Over Time

11. Different Batches of Biologics Are Similar but Not Identical

12. Similarity Assessment of a Monoclonal Antibody: Typical Attributes to Evaluate

13. The EMA Uses a Comparability Exercise to Evaluate Manufacturing Changes to Approved Biologics

14. Comparability Exercise Allows Different Product Originator Batches in the Market

15. Analytical Methods to Ensure Batch-to-Batch Consistency

16. Changes in Rituximab Properties Across Batches

17. Originator and Biosimilar Development

18. Approval of Biologic Manufacturing Changes vs Approval of a Biosimilar

19. Clinical Trial Designs Used to Evaluate Biosimilars

20. Clinical Trials Evaluating the Rituximab Biosimilar GP2013

21. Immunogenicity Varies Among Biologics

22. Role of Pharmacovigilance

23. Switching Patients From Originator to Biosimilar

24. Concluding Remarks

25. Abbreviations

26. Abbreviations (cont)