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Published byImogene Palmer Modified over 6 years ago
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Application of Biosimilars in RA IN Clinical Practice: Key Issues and Challenges
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Introduction
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Differences Between Generics and Biosimilars
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Clinical Development Program: Biosimilars
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Differences Between Development of New Generics and New Biosimilar Medications
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Clinical Trials of Biosimilars
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EMA Principles for Establishing Biosimilarity
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Postmarketing Pharmacovigilance for Biosimilars
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Immune Reactions to Biologic Therapeutics
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Considerations in Determining Immunogenicity
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Extrapolation to Other Indications
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Clinical Study of Rituximab Biosimilar Candidate CT-P10 Performed in RA
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Biosimilar Naming and Traceability
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FDA Proposal on Biosimilar Nomenclature
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Redefining "Switching"
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Patient Case 1
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Patient Case 1: A Clinician’s Perspective
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Cost: Clinician’s Perspective
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Starting a Patient on a Biosimilar: Another Clinician’s Perspective
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Patient Case 2
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Patient and Physician Considerations in a Nonmedical Switch
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Physician Considerations: Nonmedical Switch
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DANBIO Registry: Effect of Nonmedical Switch From Originator to Biosimilar Infliximab
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Adherence Results for the DANBIO Registry After a Nonmedical Switch
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Importance of Doctor-Patient Communication
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Switching Between Multiple Biosimilars?
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Patient Case 3
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Adherence in RA: Generally Low for Conventional Treatments
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Encouraging Adherence and Informing the Patient
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Acceptance of Biosimilars
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Concluding Remarks
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Abbreviations
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