Biologics, Biosimilars, and Biobetters

A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists

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