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

Chapter 1: Innovator Biologics, Biosimilars and Biobetters: Terminology, Nomenclature and Definitions

Chapter 2: Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions

Chapter 3: Status of Biologic Drugs in Modern Therapeutics-Targeted Therapies vs Small Molecule Drugs

Chapter 4: Major Classes of Biotherapeutics

Chapter 5: Drug Targets for Biologics

Chapter 6: Pivotal Biology, Chemistry, Biochemistry and Biophysical Concepts of Biologics and Biosimilars

Chapter 7: Biosimilarity and Interchangeability of Biologic Drugs- General Principles, Biophysical Tests and Clinical Requirements to Demonstrate Biosimilarity

Chapter 8: Pharmacokinetics of Biologics

Chapter 9: Pharmacogenomics of Biologics

Chapter 10: International Regulatory Processes and Policies for Innovator Biologics, Biosimilars and Biobetters

Chapter 11: Pharmacovigilance of Innovator Biologics and Biosimilars

Chapter 12: Pharmacoeconomics of Biologic Medicines and Biosimilars (Gregory Reardon, Keck Graduate Institute, USA)

Chapter 13: New Emerging Biotherapies: Cutting-Edge Research to Experimental Therapies

Chapter 14: Optimising Use of Biologic Medicines Using a Quality Use of Medicines Approach

Chapter 15: Knowledge Areas and Competency Standards on Biologic Medicines for Pharmacists and Pharmacy Students

Chapter 16: A Checklist for Pharmacists on Biologics and Biosimilars - Tips to Enhance Patient-Centred Discussions

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

Iqbal Ramzan 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 Vice-President of the Australian Pharmacy Council. He is a Pharmacist and holds a Diploma from the Australian Institute of Company Directors.