Biologics, Biosimilars, and Biobetters

List of Contributors vii

Foreword ix

Preface xi

1 Innovator Biologics, Biosimilars, and Biobetters: Terminology, Nomenclature, and Definitions 1

2 Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions 17

3 Status of Biologic Drugs in Modern Therapeutics-Targeted Therapies vs. Small Molecule Drugs 31

4 Major Classes of Biotherapeutics 47

5 Drug Targets for Biologics 71

6 Pivotal Biology, Chemistry, Biochemistry, and Biophysical Concepts of Biologics and Biosimilars 89

7 Biosimilarity and Interchangeability of Biologic Drugs-General Principles, Biophysical Tests, and Clinical Requirements to Demonstrate Biosimilarity 109

8 Pharmacokinetics of Biologics 125

9 Pharmacogenomics of Biologics 147

10 International Regulatory Processes and Policies for Innovator Biologics, Biosimilars, and Biobetters 159

11 Pharmacovigilance of Innovator Biologics and Biosimilars 177

12 Pharmacoeconomics of Biologic Medicines and Biosimilars 195

13 New Emerging Biotherapies: Cutting-Edge Research to Experimental Therapies 213

14 Optimizing Use of Biologic Medicines Using a Quality Use of Medicines Approach 237

15 Knowledge Areas and Competency Standards on Biologic Medicines for Pharmacists and Pharmacy Students 253

16 A Checklist for Pharmacists on Biologics and Biosimilars: Tips to Enhance Patient-Centered Discussions 267

Index 295