ABSTRACT

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|20 pages

Biologics and Biosimilars 101

Principles and Practice

chapter 3|16 pages

Biologics and Biosimilars

Research and Development

chapter 11|16 pages

Expanding the Product Shelf

Taking Biologics and Biosimilars from the Bench to the Bedside

chapter 16|18 pages

Rising from the Ashes

The Curious Case of the Development of Biologics for the Treatment of Neuroblastoma

chapter 17|12 pages

Paradigm Shift in Cancer Therapy

Chimeric Antigen Receptor T Cell Therapy

chapter 20|28 pages

Biologics and Biosimilars

Potential Therapeutics for Autoimmune Renal Diseases

chapter 22|30 pages

Complement as New Immunotherapy Target

Past, Present, and Future

chapter 23|14 pages

Drug Discovery Approaches for Inflammatory Bowel Disease

Antibodies and Biosimilars

chapter 25|62 pages

Biologics and Biosimilars

Clinical Applications and Biomarker Testing