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

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.