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This is a comprehensive primer, study guide, and primary reference text for pharmacists, doctors, and other health practitioners that presents the relevant science, clinical, policy, and regulatory frameworks for biologic medicines. The contents are pitched at a level that is easily understandable and can be immediately applied in everyday practice.

Innovator biologics, their interchangeable equivalents, biosimilars and their more efficacious, successors, biobetters are taking up a larger share of the therapeutics drug market compared to small molecule drugs. They are potent, highly complex in their therapeutic and clinical utility and far more expensive. Pharmacists are the primary healthcare professionals who will be expected to provide advice on these drugs as governments and other third‐party payers attempt to contain their costs by introducing interchangeable biologic medicine products.

This book explores the current and emerging scientific and clinical practices. It compares different policy and regulatory approaches across countries. There is a focus on what pharmacists need to discuss with doctors and patients about the regulatory approval principles of biosimilars and evidence for interchangeability. Pharmacists and other clinicians require an understanding of the suite of biophysical tests needed to establish similarity, the likely efficacy, safety, and clinical risk(s) of switching not only from an innovator biologic to a biosimilar or a biobetter but also from any biologic medicine to another. Sound clinical and policy decisions will require health professionals to assimilate new types of information to ensure patients achieve optimal outcomes. This book will help them navigate this complex territory.

The book also provides recommendations for pharmacy educators and accreditors of pharmacy degree programs on the knowledge areas and competency standards to be met by pharmacy students and pharmacists on the entire burgeoning area of biologic medicines. Pragmatic regulatory approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical data and evidence are also provided. A checklist is provided for pharmacists to facilitate conversations with doctors and patients to ensure quality use of medicine for biologic medicines to deliver patient‐centered health outcomes.

Like many current health professionals, I had limited or no exposure to biologic medicines when I trained as a pharmacist. However, while serving as Dean of Pharmacy, at University of Sydney, for over 12 years, I had a bird's‐eye view of the profession and of many future directions in healthcare. It was clear that pharmacists would be expected to take on a greater educative role with biologic medicines and I did not necessarily believe that they were sufficiently confident or knew enough about all aspects of biologic medicines. I 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