Biologics, Biosimilars, and Biobetters: An Introduction for Pharmacists, Physicians and Other Health Practitioners / Edition 1

by Iqbal Ramzan

Overview

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

Product Details

ISBN-13:	9781119564652
Publisher:	Wiley
Publication date:	02/03/2021
Pages:	320
Product dimensions:	8.50(w) x 10.80(h) x 0.70(d)

About the Author

IQBAL RAMZAN 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.

Table of Contents

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

Editorial Reviews

Reviewer: Nur Kazzaz, PharmD (Temple University Hospital)
Description: This book serves as an introductory reference on biologic therapies, using tables, drawings and sketches as well as outline information.
Purpose: The purpose of this book is to serve as a healthcare reference on biologic therapies by addressing biologic therapy in clinical practice and providing recommendations for clinicians and educators. Given its level of detail, the book surpasses its objectives.
Audience: This book is written for clinicians of all specialties to learn about biologic therapy. Biologics can be intimidating and many clinicians do not have exposure to their use in practice. The author is a pharmacist and a dean who has chosen to research this topic given the gap in knowledge of healthcare professionals.
Features: The book begins by discussing terminology as it pertains to biologics, followed by regulatory practices. It describes the structures of biologics as well as their pharmacokinetic and pharmacodynamic properties. Colored photos are used to help with the 3D depiction of these therapies. The book could have gone into more therapies to make it more inclusive.
Assessment: This book is extremely useful. In my current practice, we use biologic therapies as a mainstay with our severe asthmatic patients. It is difficult to find references for questions that are asked beyond what is found in clinical trials. This book describes structures and nomenclature, which is helpful for understanding a new therapy. The book uses pictures to help conceptualize molecular mass of medication, such as in figure 3.1, which shows the evolution of aspirin to a monoclonal antibody.

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