Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 2
Table of Contents
Оглавление1 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
12 6 Pivotal Biology, Chemistry, Biochemistry, and Biophysical Concepts of Biologics and Biosimilars Abbreviations 6.1 Definitions: Biologics vs. Small Molecule Drugs 6.2 Biochemical and Biophysical Properties 6.3 Chemical and Physical Stability 6.4 Formulation Considerations and Devices 6.5 Analytical Methods/Tools 6.6 Influenza Vaccines References
13 7 Biosimilarity and Interchangeability of Biologic Drugs‐ General Principles, Biophysical Tests, and Clinical Requirements to Demonstrate Biosimilarity Abbreviations 7.1 Introduction 7.2 Interchangeability 7.3 Conclusions References
14 8 Pharmacokinetics of Biologics Abbreviations 8.1 Introduction 8.2 Pharmacokinetics and Pharmacodynamics of Biological Medicines 8.3 Understanding Pharmacokinetic Variability for Monoclonal Antibodies 8.4 Pharmacokinetics of Biosimilar and Biobetter Biologics 8.5 Modeling and Simulation of Monoclonal Antibody Pharmacokinetics and Pharmacodynamics 8.6 Individualizing Therapy and the Role of TDM 8.7 Conclusions Acknowledgements References
15 9 Pharmacogenomics of Biologics Abbreviations 9.1 Introduction 9.2 Approaches to the Identification of Genetic Variants Influencing Response to Biologic Medicines 9.3 Pharmacogenomics of Biologics in Rheumatoid Arthritis 9.4 Pharmacogenomics of Biologics in Inflammatory Bowel Disease (IBD) 9.5 Pharmacogenomics of Biologics in Psoriasis 9.6 Pharmacogenomics of Biologics in Age‐Related Macular Degeneration (AMD) 9.7 Pharmacogenomics of Biologics in Asthma and Chronic Obstructive Pulmonary Disease 9.8 Conclusions References
16 10 International Regulatory Processes and Policies for Innovator Biologics, Biosimilars, and Biobetters Abbreviations 10.1 Introduction 10.2 Major International Regulatory Agencies 10.3 General Requirements for Biologics Approval 10.4 Specific Requirements for Innovator/Reference Biologics and Biosimilars 10.5 Approval of Biobetters 10.6 Conclusions References
17 11 Pharmacovigilance of Innovator Biologics and Biosimilars Abbreviations 11.1 Introduction 11.2 Premarketing Period 11.3 Post‐marketing Period 11.4 New Directions 11.5 Conclusions References
18 12 Pharmacoeconomics of Biologic Medicines and Biosimilars Abbreviations 12.1 Pharmacoeconomics of Innovator Biologics 12.2 Variation in Usage of Innovator Biologics 12.3 Payer Management of Innovator Biologic Costs 12.4 Value of Innovator Biologics 12.5 Innovator Biologic Development Costs 12.6 Coverage of Rare Disease Drugs 12.7 Pharmacoeconomics of Biosimilars 12.8 Conclusions References
19 13 New Emerging Biotherapies: Cutting‐Edge Research to Experimental Therapies Abbreviations 13.1 Introduction 13.2 Methods to Enhance Stability of Biologics 13.3 Bispecific Antibodies (bsAbs) 13.4 Antibody–Drug Conjugates 13.5 CAR T‐cell Therapy 13.6 Immune Checkpoint Antagonism 13.7 Conclusions and Future Outlook References
20 14 Optimizing Use of Biologic Medicines Using a Quality Use of Medicines Approach Abbreviations 14.1 Introduction 14.2 Quality Use of Medicines Approach 14.3 Influences on Prescribing and Use of Biologic Medicines 14.4 Policy to Support Appropriate Uptake of Biologic Medicines 14.5 Formulary Management 14.6 Sources of Information and Education 14.7 Adherence and Persistence 14.8 Cost‐effectiveness Considerations 14.9 Monitoring and Real‐World Experience 14.10 Conclusions References
21 15 Knowledge Areas and Competency Standards on Biologic Medicines for Pharmacists and Pharmacy Students Abbreviations 15.1 Chapter Background 15.2 Current Knowledge of Pharmacists and Pharmacy Students About Biologics 15.3 Prescriber Knowledge of Biologic Medicines 15.4 Pharmacist’s Role in Biologic Medicine Education 15.5 General Background on Biologic Medicines 15.6 History of Pharmacy Education 15.7 Accreditation of Pharmacy Degrees 15.8 Content of Pharmacy Degree Curricula 15.9 Recommended Knowledge Areas on Biologics in the Published Literature 15.10 Modes of Learning and Teaching Delivery and Assessments 15.11 Urgent Need for Curriculum Reform 15.12 Concluding Remarks References
22 16 A Checklist for Pharmacists on Biologics and Biosimilars: Tips to Enhance Patient‐Centered Discussions Abbreviations 16.1 Context of This Checklist for Pharmacists and Health Professionals 16.2 Summary of Biologics, Biosimilars, and Biobetters 16.3 Storage and Handling of Biologics 16.4 Regulatory Requirements 16.5 Naming and Labeling of Biologic Therapies 16.6 Funding of Biosimilars: Australian Approach 16.7 Pharmacovigilance 16.8 Medicines Use Evaluation 16.9 Reducing Clinical Risks from Innovator Biologics, Biosimilars, and Biobetters 16.10 Checklist on Biologics 16.11 Practice Points: Anticipated Questions from Health Professionals 16.12 Practice Points: Anticipated Questions from Patients References
23 Index
