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Biosimilars in Immune-Related Diseases

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Presentation on theme: "Biosimilars in Immune-Related Diseases"— Presentation transcript:

1 Biosimilars in Immune-Related Diseases

2 Introduction

3 Anti-TNF Biosimilars Approved in EU

4 Upcoming Adalimumab Biosimilar Launches in Europe

5 Differences Between Biologics and Small Molecules

6 Biologic Manufacturing Process and Source of Variation

7 Key Features of Biosimilars -- EMA

8 Route to Approval: Biologics vs Biosimilars

9 Key Steps in the Biosimilar Development Process

10 The Concept of Extrapolation

11 The Concept of Extrapolation (cont)

12 Switching -- Expert Perspective

13 Importance of Communication Strategy in Switching

14 Meta-Analyses on Switching From Reference Medicines to Biosimilars

15 Switching -- Expert Practice Experience

16 Switching Patients From Originator to Biosimilar -- Rheumatology Experience

17 Switching Patients From Originator to Biosimilar -- Dermatology Experience

18 Position Statement on Biosimilars

19 Position Statement on Biosimilars -- Experts' Perspectives

20 Concluding Remarks

21 Concluding Remarks (cont)

22 Abbreviations


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