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
