1st Edition

Biologics and Biosimilars Drug Discovery and Clinical Applications

    528 Pages 7 Color & 44 B/W Illustrations
    by CRC Press

    528 Pages 7 Color & 44 B/W Illustrations
    by CRC Press

    Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases.

    This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines.

    Additional features:

    • Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars
    • Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars
    • Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars

    This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.

    Chapter 1: Biologics and Biosimilars 101: Principles and Practice. Chapter 2: Frontiers in Biopharmaceutical Development of Biologics and Biosimilars: Opportunities and Challenges Chapter 3: Biologics and Biosimilars: Research and Development. Chapter 4: Vaccines as Biologics in the Era of Pandemic. Chapter 5: Therapeutic Delivery Systems for Biologics and Biosimilars. Chapter 6: Legislative and Regulatory Pathways for Biosimilars. Chapter 7: The Development of Biologics from the Perspective of the Pharmaceutical Industry. Chapter 8: The Manufacturing and Quality Assurance Process for Biologics and Biosimilars. Chapter 9: Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics of Biological Products. Chapter 10: Understanding Variability, Stability, and Immunogenicity of Biosimilars. Chapter 11: Expanding the Product Shelf: Taking Biologics and Biosimilars from the Bench to the Bedside. Chapter 12: Hydrogel-Based Delivery of Biologics in Cancer and Cardiovascular Diseases: Proof-of-Concept. Chapter 13: Clinical Use of Biologics and Biosimilars in Oncology Settings. Chapter 14: Monoclonal Antibodies in Cancer Therapeutics. Chapter 15: Molecule-Targeted Drugs That Treat Colorectal Cancer. Chapter 16: Rising from the Ashes: The Curious Case of the Development of Biologics for the Treatment of Neuroblastoma. Chapter 17: Paradigm Shift in Cancer Therapy: Chimeric Antigen Receptor T Cell Therapy. Chapter 18: Biologics and Biosimilars Used for Diabetes. Chapter 19: Clinical Use of Biologics and Biosimilars in Asthma. Chapter 20: Biologics and Biosimilars: Potential Therapeutics for Autoimmune Renal Diseases. Chapter 21: Therapeutics of Recombinant Human Clotting Factor VIII (rhFVIII) for Hemophilia A. Chapter 22: Complement as New Immunotherapy Target: Past, Present, and Future. Chapter 23: Drug Discovery Approaches for Inflammatory Bowel Disease: Antibodies and Biosimilars. Chapter 24: Transformative Stem Cell-Based Therapy in Neurological Diseases and Beyond. Chapter 25: Biologics and Biosimilars: Clinical Applications and Biomarker Testing. Chapter 26: Application of Modeling and Simulation in the Development of Biologics and Biosimilars. Chapter 27 Machine Learning Applications in Biologics and Biosimilars: Disruptive Innovation.


    Xiaodong Feng, Hong-Guang Xie, Ashim Malhotra, Catherine F. Yang