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Biosimilars in Immune-Related Diseases
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Introduction
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Anti-TNF Biosimilars Approved in EU
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Upcoming Adalimumab Biosimilar Launches in Europe
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Differences Between Biologics and Small Molecules
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Biologic Manufacturing Process and Source of Variation
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Key Features of Biosimilars -- EMA
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Route to Approval: Biologics vs Biosimilars
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Key Steps in the Biosimilar Development Process
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The Concept of Extrapolation
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The Concept of Extrapolation (cont)
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Switching -- Expert Perspective
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Importance of Communication Strategy in Switching
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Meta-Analyses on Switching From Reference Medicines to Biosimilars
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Switching -- Expert Practice Experience
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Switching Patients From Originator to Biosimilar -- Rheumatology Experience
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Switching Patients From Originator to Biosimilar -- Dermatology Experience
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Position Statement on Biosimilars
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Position Statement on Biosimilars -- Experts' Perspectives
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Concluding Remarks
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Concluding Remarks (cont)
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Abbreviations
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