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Application of Biosimilars in RA IN Clinical Practice: Key Issues and Challenges  

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Presentation on theme: "Application of Biosimilars in RA IN Clinical Practice: Key Issues and Challenges  "— Presentation transcript:

1 Application of Biosimilars in RA IN Clinical Practice: Key Issues and Challenges  

2

3 Introduction

4 Differences Between Generics and Biosimilars

5 Clinical Development Program: Biosimilars

6 Differences Between Development of New Generics and New Biosimilar Medications

7 Clinical Trials of Biosimilars

8 EMA Principles for Establishing Biosimilarity

9 Postmarketing Pharmacovigilance for Biosimilars

10 Immune Reactions to Biologic Therapeutics

11 Considerations in Determining Immunogenicity

12 Extrapolation to Other Indications

13 Clinical Study of Rituximab Biosimilar Candidate CT-P10 Performed in RA

14 Biosimilar Naming and Traceability

15 FDA Proposal on Biosimilar Nomenclature

16 Redefining "Switching"

17 Patient Case 1

18 Patient Case 1: A Clinician’s Perspective

19 Cost: Clinician’s Perspective

20 Starting a Patient on a Biosimilar: Another Clinician’s Perspective

21 Patient Case 2

22 Patient and Physician Considerations in a Nonmedical Switch

23 Physician Considerations: Nonmedical Switch

24 DANBIO Registry: Effect of Nonmedical Switch From Originator to Biosimilar Infliximab

25 Adherence Results for the DANBIO Registry After a Nonmedical Switch

26 Importance of Doctor-Patient Communication

27 Switching Between Multiple Biosimilars?

28 Patient Case 3

29 Adherence in RA: Generally Low for Conventional Treatments

30 Encouraging Adherence and Informing the Patient

31 Acceptance of Biosimilars

32 Concluding Remarks

33 Abbreviations


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