Biologics and Biosimilars : Drug Discovery and Clinical Applications book cover
1st Edition

Biologics and Biosimilars
Drug Discovery and Clinical Applications

ISBN 9781138594227
Published June 14, 2022 by CRC Press
528 Pages 7 Color & 44 B/W Illustrations

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Book Description

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.

Table of Contents

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.

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Dr. Xiaodong Feng received his Ph.D. training in Cellular and Molecular Physiology and PharmD training specialized in pharmacy education and clinical pharmacy practice. He started biomedical research career twenty years ago in the Wound Healing Center, School of Medicine at Stony Brook. After three years of fellowship, he continued research and teaching as an Assistant Professor in Department of Dermatology, School of Medicine, State University of New York at Stony Brook for another 4 years. Currently he is teaching at California Northstate University College of Medicine as Professor of Pharmacology and Oncology. He also has administrative role as University Vice President and Associate Dean for Student Affairs, Admissions and Outreach at California Northstate University College of Medicine. He has over twenty years of clinical and biomedical research experience in cancer, wound healing, and cardiovascular diseases. He also practices as a clinical pharmacist and oncology pharmacy specialist. His current research interests include drug discovery for anti-angiogenesis therapy and tumor metastasis, and application of pharmacogenomics in patient care. Two US patents on strategies of anti-angiogenesis and cancer treatments have recently been issued for Dr. Feng. Personalizing pharmacotherapy using pharmacogenomics has always been his professional passion. He also edited a text book on clinical application of pharmacogenomics in therapeutics. He has been serving as editorial board members and peer reviewers for several peer reviewed biomedical and pharmaceutical journals.

Hong-Guang Xie, MD, PhD, earned his bachelor’s degree of medicine (MD equivalent), master’s degree of medicine, and doctoral degree of medicine (PhD equivalent) in 1984, 1989, and 1995, respectively, from Central South University Xiangya (formerly Xiang-Yale) School of Medicine, Changsha, Hunan, China, where he was promoted as a lecturer and associate professor of pharmacology in 1989, and 1995, respectively, and subsequently selected as a mentor of graduate students for master’s degree in pharmacology. He was appointed as the first associate director of the Pharmacogenetics Research Institute (currently Institute of Clinical Pharmacology), Central South University, China, as the co-founder of that institute in 1997. As a recipient of the Merck Sharp and Dohme (MSD) International Clinical Pharmacology Fellowship, Dr. Xie joined Vanderbilt University School of Medicine (Nashville, Tennessee, USA) as a research fellow (postdoc) in 1997 and a research instructor (faculty) in pharmacology in 2002. After that, he joined the University of California at San Francisco (UCSF) Washington Center at Washington, DC, as staff (a research fellow) in 2008, and the US FDA in 2010 as an Oak Ridge Institute for Science and Education (ORISE) fellow. In December 2011, Dr. Xie joined Nanjing Medical University (Nanjing, Jiangsu, China) as a full professor of pharmacology and a mentor of PhD students and was appointed as chief of General Clinical Research Center (GCRC), Nanjing First Hospital. In 2014, Dr. Xie was awarded as a recipient of the Distinguished Medical Expert of Jiangsu Province, China. In 2015, he joined China Pharmaceutical University (Nanjing, China) jointly as a mentor of the PhD training program for clinical pharmacy.

Dr. Xie is active in the research field of basic and clinical pharmacology, with at least 140 articles (original, review, and commentary) published, many of which published in some leading journals worldwide, such as New England Journal of Medicine, Annual Review of Pharmacology & Toxicology, Advanced Drug Delivery Review, Pharmacology & Therapeutics, British Journal of Pharmacology, Clinical Pharmacology & Therapeutics, Biochemical Pharmacology, Journal of Thrombosis & Haemostasis, Drug Metabolism Review, Drug Metabolism and Disposition, and more. In addition, Dr. Xie has authored up to 10 chapters in books published by Annual Reviews, Springer, Wiley, ASM Press, and CRC Press abroad, as well as the People’s Medical Publishing House, Beijing, China, of which he served as a co-editor and associated editor for 2 books, respectively. Dr. Xie has served on the editorial board of BMC Medical Genomics (associate editor), Pharmacogenomics, UK (2003 – 2011), American Journal of PharmacoGenomics (currently Molecular Diagnosis and Therapy), New Zealand, and Journal of Geriatric Cardiology, China. Dr. Xie has also been invited as a manuscript reviewer by over 40 biomedical and pharmacological journals published predominantly in the North America and Europe.

Ashim Malhotra, Pharm.BS, MS, PhD, FAPE is a pharmacist, an NYU Grossman School of Medicine-trained and extramurally-funded molecular pharmacologist, and a pharmacy educator with over fifteen years of academic experience.  

He serves as Assistant Dean for Accreditation and Program Development, University Distinguished Teacher, and associate professor at the California Northstate University (CNU) College of Pharmacy (COP). He is Director of the CNU Institute of Teaching and Learning Excellence and also directs the University’s interprofessional education and practice program. In these roles, he leads faculty development activities for CNU’s six colleges of Medicine, Pharmacy, Health Sciences, Psychology, Graduate Studies, and Dental Medicine.  

Malhotra earned a Bachelor of Pharmacy degree in 2000, and MS (2003), and PhD (2006) degrees specializing in molecular pharmacology from St. John's University in New York City. He conducted postdoctoral work at the New York University (NYU) Grossman School of Medicine. Elected lifetime Fellow of the American Academy of Pharmacology Educators of the American Society of Pharmacology and Experimental Therapeutics in 2020, his work has been recognized through institutional and national awards.  


Dr. Malhotra has a rich history of mentoring Pharm.D. and undergraduate students and postdoctoral fellows in bench and pedagogy research. For seven continuous years (2014-2021), work conducted by his students was recognized through national awards such as the 2021 and 2019 AACP Walmart Scholar, 2015-2018 American Society of Pharmacology and Experimental Therapeutics (ASPET) travel awards, 2017 First prize winner at the Dolores Shockley ASPET poster competition, among others. 


He has published over 44 peer-reviewed journal articles and book chapters, more than 80 conference abstracts, presented 32 invited national podium sessions, chaired an international conference in pancreatic cancer, edited two books, and garnered $374,000 in research funding with an emphasis on mitochondrial pharmacology and also the scholarship of teaching and learning. He keeps Pacific Standard Time, enjoys the snowy Sierras, theatre, poetry, and reading.  



Catherine F. Yang, PhD, Vice President of Academic Affairs, Interim Dean, College of Medicine and Professor of Molecular Pharmacology/Medicinal Chemistry/Biomedical Sciences. Dr. Yang received her Master and PhD from Tufts University followed by postdoctoral training in Molecular Pharmacology/Clinical Biochemistry from Harvard Medical School.  

Dr. Yang is a Professor of Molecular Pharmacology and Clinical Biochemistry at the Department of Basic Science of College of Medicine of California Northstate University (CNU). Before joining CNU in 2016, Dr. Yang was a Biochemistry & Pharmacology Professor at Rowan University and held a faculty appointment at its Cooper Medical School. She has also held research and faculty positions at Harvard Medical School, the American Health Foundation, Boston Biomedical Research Institute, Tokyo University of Medicine and Dentistry, University of Pennsylvania, and Zhejiang University of Technology. Dr. Yang has over 25 years of teaching experience in the areas of medicinal chemistry, molecular pharmacology and clinical biochemistry. 

Dr. Yang's research has made strong contributions in elucidating mechanisms of tumor progression, in the development of novel cancer drugs. and antibiotics. She has led research groups studying proteolytic regulatory mechanisms in the advanced stages of prostate cancer, lung cancer, and leukemia. Her in-depth research on type 2 diabetic metabolic regulation led to a dual function diabetes drug patent. Dr. Yang’s immunological research resulted in an allergy vaccine development that is currently under clinical trials at affiliated clinics.  

Dr. Yang has published more than 70 research papers, several biotechnology books, and is an inventor of 10 patented inventions. She has also secured numerous grants from the NIH, NSF, Research Corporation and New Jersey Health Foundation as well as funding from many pharmaceutical corporations and health foundations. She serves on various review boards of federal, private and health foundation funding agencies.