1. Applying Biosimilars in Oncology Practice: What Do You Need to Know?

2. Introduction

3. What Is a Biosimilar?

4. How Do Biosimilars Compare With Small Molecules Generics?

5. Biosimilars Have Increased in Size and Complexity

6. Biosimilar Guidance: EMA 2017

7. The Principles of Biosimilar Development as Detailed in Guidelines Is Based on the Totality of Evidence

8. The Stepwise Approach to Establish the Totality of Evidence

9. Equivalence Studies Are Necessary to Demonstrate Biosimilarity

10. Monoclonal Antibodies Have Many Quality Attributes That Must Be Characterized With Analytical Methods

11. Cost Considerations

12. Pharmacovigilance

13. Definitions of Substitution, Switching, and Interchangeability

14. Recommendations for Switching and Substitution of Biosimilars

15. Conclusions

16. Abbreviations