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What Is a Biosimilar?. Biosimilar Application in RA Clinical Practice: Current Knowledge and New Data  

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Presentation on theme: "What Is a Biosimilar?. Biosimilar Application in RA Clinical Practice: Current Knowledge and New Data  "— Presentation transcript:

1 Biosimilar Application in RA Clinical Practice: Current Knowledge and New Data  

2 What Is a Biosimilar?

3 Differences Between Generics and Biosimilars

4 Clinical Development Program: Biosimilars

5 Differences Between Development of New Generics and New Biosimilar Medications

6 Concluding Remarks

7 Biosimilars in RA

8 ACR Improvement Results at Week 54: PLANETRA Trial

9 54-Week Results From a Phase 3 Study of SB2 vs Infliximab

10 Phase 3 Trial Results of HD203 vs Etanercept in Patients With Active RA

11 Phase 3 Study of SB4 vs Etanercept in Patients With Active RA Despite Methotrexate Therapy

12 Results of a Phase 3 Study of SB4 vs Etanercept in Patients With Active RA Despite Methotrexate Therapy

13 Phase 3 Efficacy and Safety Study of ABP 501 vs Adalimumab in Moderate to Severe RA

14 Results of Phase 3 Efficacy and Safety Study of ABP 501 vs Adalimumab in Moderate to Severe RA

15 Concluding Remarks

16 Switching (or Transition) Results: Reference Biologics and Biosimilars

17 NOR-SWITCH Study of Switching From Infliximab to CT-P13 Biosimilar

18 Results for NOR-SWITCH Study of Infliximab and CT-P13

19 DANBIO Registry: A Nationwide Nonmedical Switch From Originator to Biosimilar Infliximab in Inflammatory Arthritis

20 DANBIO Registry: Effect of Nonmedical Switch From Originator to Biosimilar Infliximab on ADAs

21 Results From a Nationwide Nonmedical Switch From Originator to Biosimilar Infliximab

22 Clinical and Immunogenicity Outcomes After Switch From Originator Infliximab to Biosimilar

23 Results for Clinical and Immunogenicity Outcomes After Switch to Infliximab Biosimilar

24 Concluding Remarks

25 Results from Recent Phase 3 and Long-Term Trials

26 Phase 3 Efficacy and Safety of CT-P10: A Rituximab Biosimilar Candidate in Patients With RA

27 Results for Efficacy and Safety of CT-P10

28 Phase 3 Efficacy and Safety of Transition to SB2 vs Ongoing Infliximab in RA

29 Safety Results for Transition to SB2 vs Ongoing Infliximab in RA

30 Open-Label Extension Study of Long-Term Efficacy and Safety of ABP 501, a Biosimilar Candidate to Adalimumab

31 Interim Results of Ongoing Open-Label Extension Study of ABP 501

32 Concluding Remarks

33 Patient Attitudes Toward Biosimilars

34 QoL Outcomes Following Biosimilar Candidate Chs-0214 and Etanercept in RA

35 Results for QoL Improvements With Chs-0214 and Etanercept in RA

36 Patient Survey Regarding Generic and Biosimilar Drugs in Japan

37 Results of Patient Survey Regarding Generic and Biosimilar Drugs in Japan

38 Patient Attitudes Toward Receiving Biosimilars in Inflammatory Autoimmune Diseases in Germany

39 Concluding Remarks

40 Abbreviations

41 Abbreviations (cont)


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