- 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
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
