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
List of Tables
1 Chapter 1Table 1.1 Broad categories of biologic medicines.Table 1.2 Definitions of biosimilars by major regulatory agencies.Table 1.3 Pivotal differences between biologics and small molecule drugs.Table 1.4 Abbreviations used in biologic medicine literature.
2 Chapter 3Table 3.1 Best‐selling drugs ranked by sales volume.Table 3.2 Characteristics of small molecule pharmaceuticals vs. biologics.Table 3.3 Preclinical and clinical trial data exclusivity by nation.Table 3.4 A history of vaccine development and regulation in the United State...Table 3.5 Examples of cytokine drugs and diseases treated.Table 3.6 Insulin: timeline of discovery and manufacture.
3 Chapter 4Table 4.1 Major classes of biotherapeutics.
4 Chapter 6Table 6.1 Comparison of common characteristics of biologics and small molecul...Table 6.2 Nomenclature/naming of therapeutic monoclonal antibodies.Table 6.3 Summary of commonly used biophysical methods used in biologics rese...
5 Chapter 7Table 7.1 Representative example of quality attributes for a monoclonal antib...
6 Chapter 8Table 8.1 Monoclonal antibody nomenclature, humanized component, and examples...Table 8.2 Pharmaceutical, pharmacokinetic, and pharmacodynamic differences be...Table 8.3 Pharmacokinetic parameters for selected therapeutic proteins includ...Table 8.4 Examples of monoclonal antibodies with membrane‐bound and shed targ...Table 8.5 Drug interactions involving monoclonal antibodies.2,49
7 Chapter 10Table 10.1 Comparison of biosimilar regulations and guidelines internationall...
8 Chapter 11Table