1. Biosimilars in Hematologic Oncology

3. Brief History of Biosimilars

4. Biologics Manufacturing Process

5. Variabilities in Originator* Biologics and Biosimilars

6. Manufacturing Changes to Originator Biologics Across all Therapeutic Areas

7. Manufacturing Changes in Originator Biologic Rituximab

8. Changes to Biologics and Totality of Evidence

9. Regulatory Approval Process for Originator Biologics and Biosimilars

10. Differences Between Generics and Biosimilars

11. Regulatory Requirements for Changes in Manufacturing of Original Biologics and Biosimilar Development

12. Typical Quality Attributes to Be Evaluated in Similarity Assessment of a Monoclonal Antibody

13. Clinical Endpoints Supporting the Use of Biosimilars

14. Concerns Regarding Switching to Another Originator Drug or a Biosimilar: Immunogenicity

15. Oncologics Account for Highest Drug Class Spending in the United States

16. Ease of Access to Rituximab in Hem/Onc

17. The Impact of Biosimilar Filgrastim in Oncology

18. In Europe: The Vocabulary Distinguishes Replacement by Different Agents in the Process

19. Challenges in Switching to Biosimilars

20. Outcomes From Switching Studies

21. Clinical Data From Most Advanced Biosimilars in Hem/Onc: CT-P10 Study Design

22. Clinical Data From Most Advanced Biosimilars in Hem/Onc: CT-P10 PK Outcomes

23. Clinical Data From Most Advanced Biosimilars in Hem/Onc: CT-P10 Safety

24. Clinical Data From Most Advanced Biosimilars in Hem/Onc: GP-2013 Study Design

25. Clinical Data From Most Advanced Biosimilars in Hem/Onc: GP-2013 Efficacy Outcomes

26. Clinical Data From Most Advanced Biosimilars in Hem/Onc: GP-2013 Safety

27. Extrapolation of Indication

28. Conclusions

29. Abbreviations

30. Abbreviations (cont)

31. Abbreviations (cont)