therefore approached Jonathan Rose at Wiley and put forward a book proposal on biologic medicines. With his support, the proposal was approved after several iterations and I managed to assemble a very talented group of scientists and health professionals who were willing to share this journey with me.
Whether you are a pharmacist, a pharmacy student looking forward to entering professional practice, or a family doctor or specialist prescriber, I hope this book will empower you to understand the complexities of biologic medicines so that you can have an evidence‐based and objective conversation with your patients. There is much hype and many anecdotes, and it is critical to separate these from the facts and data that support use of these important new medicines.
Editing this book (and writing two chapters) has been a very challenging task, probably because I underestimated the enormity of the challenge. The sheer breath of the scientific and clinical literature on biologic medicines is breathtaking. In addition, the literature and the evidence base are evolving so rapidly. If I had correctly gauged how much effort it would have taken me, I probably would not have embarked on this assignment. I am very pleased with the outcome largely due to the very able group of chapter contributors who have worked tirelessly with me to get the book pitched at the right level for pharmacists, doctors, and patients.
I want to thank all the contributing authors for their dedication to this book and to working with me to translate all aspects of the complex science to a level that is easily understood by busy time‐poor pharmacists and doctors. My sincere thanks also go to the team at Wiley led by Jonathan Rose who has been very supportive from the beginning and Aruna Pragasam for assisting on the book submission.
I would also like to thank my wife, Dr. Lynn Weekes, who has been tremendously encouraging and supportive through this challenging project even though she herself wrote her own book during much of this time. Kimberlee and Justen, your encouragement to finish the project is also appreciated.
I dedicate this book to my late mum (Amma) who gave me such a strong work ethic and taught me perseverance.
Professor Iqbal Ramzan
Sydney Pharmacy School,
Faculty of Medicine and Health,
The University of Sydney,
Sydney, New South Wales, Australia
26 June 2020
1 Innovator Biologics, Biosimilars, and Biobetters: Terminology, Nomenclature, and Definitions
Iqbal Ramzan
Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
KEY POINTS
Many different terms are used for innovator biologics, biosimilars, and biobetters internationally.
Greater harmonization of terminology, definitions, and nomenclature across different regulatory jurisdictions and countries would assist health practitioners and patients in understanding the complex issues of biologic medicines.
The salient language of innovator biologics, biosimilars, and biobetters are introduced in this chapter to set the context for the rest of the book, which deals with specific issues in greater detail pitched at pharmacists, doctors, and patients.
Abbreviations
| Abbreviation | Full name |
| ABPI | Association of British Pharmaceutical Industry |
| AfPA | Alliance for Patient Access |
| BAP | Biosimilars Action Plan |
| BLA | Biologics License Application |
| BPC | Biologics Prescribers Collaborative |
| BPCI Act | Biologics Price Competition and Innovation Act |
| CAR‐T | Chimeric Antigen Receptor Therapy |
| CHMP | Committee for Medicinal Products for Human Use (EMA) |
| CIOMS | Council of International Organizations of Medical Sciences |
| CQAs | Critical Quality Attributes |
| CVMP | Committee for Medicinal Products for Veterinary Use |
| Da | Dalton |
| DNA | Deoxyribonucleic Acid |
| EMA | European Medicines Agency |
| EPAR | European Public Assessment Report |
| EU | European Union |
| FDA | Food and Drug Administration |
| GABi/GaBI | Generics and Biosimilars Initiative |
| LDN | Limited Distribution Network |
| mAbs | monoclonal Antibodies |
| NHS | National Health Service |
| NICE | National Institute for Clinical Excellence |
| NMS | Non‐Medical Switching |
| NOBs | Non‐Original Biologics |
| PBS | Pharmaceutical Benefits Scheme |
| P&T | Pharmacy & Therapeutics (Committee) |
| PTMs | Post‐Translational Modifications |
| QbD | Quality by Design |
| QUM | Quality Use of Medicine |
| RMP | Risk Management Plan |
| RPS | Reference Product Sponsor |
| RWE | Real‐World Evidence |
| SEBs | Subsequent‐Entry Biologics |
| SMD | Small Molecule Drug |
| UMC | Uppsala Monitoring Centre |
| UNESCO | United Nations Educational, Scientific and Cultural Organization |