Biologics, Biosimilars, and Biobetters
An Introduction for Pharmacists, Physicians and Other Health Practitioners
1. Edition March 2021
320 Pages, Softcover
Wiley & Sons Ltd
Short Description
This book explores the fundamental scientific, clinical, policy, and regulatory issues surrounding biologics, biosimilars, and biobetters from a practical and clinical perspective. Pharmacists require an understanding of the battery of biophysical tests needed to establish equivalence, efficacy, safety, and clinical risks of switching not only from an originator biologic to a biosimilar or a biobetter but from any biologic compound to another. There are also practical considerations such as dosing schedules and method(s) of administration that should be considered alongside efficacy, safety and cost when deciding on specific agents. The book provides regulators pragmatic approaches to deal with these drugs in the context of rapidly evolving scientific and clinical evidence. It concludes with a checklist for pharmacists to facilitate conversations with physicians and advice to patients to ensure quality use of medicine (QUM) for biologics, biosimilars, and biobetters.
Further versions
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
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
