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<p>List of Contributors vii</p> <p>Foreword ix</p> <p>Preface xi</p> <p>1 Innovator Biologics, Biosimilars, and Biobetters: Terminology, Nomenclature, and Definitions 1</p> <p>2 Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions 17</p> <p>3 Status of Biologic Drugs in Modern Therapeutics-Targeted Therapies vs. Small Molecule Drugs 31</p> <p>4 Major Classes of Biotherapeutics 47</p> <p>5 Drug Targets for Biologics 71</p> <p>6 Pivotal Biology, Chemistry, Biochemistry, and Biophysical Concepts of Biologics and Biosimilars 89</p> <p>7 Biosimilarity and Interchangeability of Biologic Drugs-General Principles, Biophysical Tests, and Clinical Requirements to Demonstrate Biosimilarity 109</p> <p>8 Pharmacokinetics of Biologics 125</p> <p>9 Pharmacogenomics of Biologics 147</p> <p>10 International Regulatory Processes and Policies for Innovator Biologics, Biosimilars, and Biobetters 159</p> <p>11 Pharmacovigilance of Innovator Biologics and Biosimilars 177</p> <p>12 Pharmacoeconomics of Biologic Medicines and Biosimilars 195</p> <p>13 New Emerging Biotherapies: Cutting-Edge Research to Experimental Therapies 213</p> <p>14 Optimizing Use of Biologic Medicines Using a Quality Use of Medicines Approach 237</p> <p>15 Knowledge Areas and Competency Standards on Biologic Medicines for Pharmacists and Pharmacy Students 253</p> <p>16 A Checklist for Pharmacists on Biologics and Biosimilars: Tips to Enhance Patient-Centered Discussions 267</p> <p>Index 295</p>

<p><b>IQBAL RAMZAN</b> is Professor of Pharmaceutical Sciences at The University of Sydney's School of Pharmacy, having recently stepped down as Dean after 12 years (2006-2017). Professor Ramzan is a recognized expert in drug pharmacokinetics/pharmacodynamics, has published 150 refereed papers, and has provided high level advice to the Australian Government on drug registration. He is an international leader in Pharmacy education and is a Past-President of the Asian Association of Schools of Pharmacy and the Council of Pharmacy Schools – Australia and New Zealand. Professor Ramzan is a pharmacist, holds a PhD from The University of Sydney, and has an academic career spanning over 40 years.

<p>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. <ul> <li>Explains what pharmacists need to discuss about the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients</li> <li>Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence</li> <li>Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists</li> </ul>

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