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

Application of Biosimilars in RA IN Clinical Practice: Key Issues and Challenges. Introduction. Differences Between Generics and Biosimilars. Clinical Development Program: Biosimilars. Differences Between Development of New Generics and New Biosimilar Medications.

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

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

  2. Introduction

  3. Differences Between Generics and Biosimilars

  4. Clinical Development Program: Biosimilars

  5. Differences Between Development of New Generics and New Biosimilar Medications

  6. Clinical Trials of Biosimilars

  7. EMA Principles for Establishing Biosimilarity

  8. Postmarketing Pharmacovigilance for Biosimilars

  9. Immune Reactions to Biologic Therapeutics

  10. Considerations in Determining Immunogenicity

  11. Extrapolation to Other Indications

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

  13. Biosimilar Naming and Traceability

  14. FDA Proposal on Biosimilar Nomenclature

  15. Redefining "Switching"

  16. Patient Case 1

  17. Patient Case 1:A Clinician’s Perspective

  18. Cost: Clinician’s Perspective

  19. Starting a Patient on a Biosimilar: Another Clinician’s Perspective

  20. Patient Case 2

  21. Patient and Physician Considerations in a Nonmedical Switch

  22. Physician Considerations:Nonmedical Switch

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

  24. Adherence Results for the DANBIO Registry After a Nonmedical Switch

  25. Importance of Doctor-Patient Communication

  26. Switching Between Multiple Biosimilars?

  27. Patient Case 3

  28. Adherence in RA:Generally Low for Conventional Treatments

  29. Encouraging Adherence and Informing the Patient

  30. Acceptance of Biosimilars

  31. Concluding Remarks

  32. Abbreviations

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