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Table of Contents
1 Cover
5 Foreword
6 Preface
7 1 Innovator Biologics, Biosimilars, and Biobetters: Terminology, Nomenclature, and Definitions Abbreviations 1.1 Place of Biologics in Modern Therapeutics 1.2 Background to Terminology, Nomenclature, and Definitions 1.3 Innovator Biologics, Biosimilars, and Biobetters 1.4 Differences Between Biosimilars and Generic Medicines 1.5 Interchangeability, Switchability, and Substitution 1.6 Other Clinical Considerations with Biosimilars 1.7 Manufacture, Delivery, and Naming Considerations 1.8 Listing of Approved Biologics 1.9 Biosimilar Initiatives and Organizations 1.10 Common Terms Used in the Biologics Literature 1.11 Abbreviations Associated with Biologic Medicines 1.12 Concluding Remarks Acknowledgement References
8 2 Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions Abbreviations 2.1 Regulatory Frameworks 2.2 Major Regulatory Jurisdictions 2.3 Maturation of the Biologic Market 2.4 Player Archetypes in a Maturing Market 2.5 Outlook: Landscape of the Biologic Market 2.6 Technology and Science Innovation in the Long Term? 2.7 The Arrival of Major Biosimilars 2.8 Biosimilars in Emerging Markets 2.9 Top 10 Biologic Drugs in the United States 2.10 Top 10 Biologic Drugs in the EU 2.11 Conclusions References
9 3 Status of Biologic Drugs in Modern Therapeutics‐Targeted Therapies vs. Small Molecule Drugs Abbreviations 3.1 Biologics in Contemporary Medicine 3.2 Clinical Characteristics of Biologic Drugs 3.3 rDNA and Biologic Drug Manufacturing 3.4 What Does the Future Hold? 3.5 Global Biologics Market 3.6 Summary References
10 4 Major Classes of Biotherapeutics Abbreviations 4.1 Major Classes of Biotherapeutics 4.2 Antibodies and Antibody‐Based Therapeutics 4.3 Alternative mAb‐Based Therapeutics 4.4 Therapeutic Signaling Molecules 4.5 Blood‐Related Products 4.6 Biosimilars References
11 5 Drug Targets for Biologics Abbreviations 5.1 Introduction 5.2 Immune Checkpoints 5.3 Human Epidermal Growth Factor Family 5.4 Vascular Endothelial Growth Factor 5.5 Interleukins 5.6 Tumor Necrosis Factor 5.7 Receptor Activator of Nuclear Factor‐ΚB Ligand (RANKL) 5.8 Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) 5.9 Concluding Remarks References
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