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

Clinical Trials of Biosimilars

EMA Principles for Establishing Biosimilarity

Postmarketing Pharmacovigilance for Biosimilars

Immune Reactions to Biologic Therapeutics

Considerations in Determining Immunogenicity

Extrapolation to Other Indications

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

Biosimilar Naming and Traceability

FDA Proposal on Biosimilar Nomenclature

Redefining "Switching"

Patient Case 1

Patient Case 1: A Clinician’s Perspective

Cost: Clinician’s Perspective

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

Patient Case 2

Patient and Physician Considerations in a Nonmedical Switch

Physician Considerations: Nonmedical Switch

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

Adherence Results for the DANBIO Registry After a Nonmedical Switch

Importance of Doctor-Patient Communication

Switching Between Multiple Biosimilars?

Patient Case 3

Adherence in RA: Generally Low for Conventional Treatments

Encouraging Adherence and Informing the Patient

Acceptance of Biosimilars

Concluding Remarks

Abbreviations