Biologics and Biosimilars
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Biologics and Biosimilars

Drug Discovery and Clinical Applications

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eBook - ePub

Biologics and Biosimilars

Drug Discovery and Clinical Applications

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About This Book

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.

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Yes, you can access Biologics and Biosimilars by Xiaodong Feng, Hong-Guang Xie, Ashim Malhotra, Catherine F. Yang, Xiaodong Feng, Hong-Guang Xie, Ashim Malhotra, Catherine F. Yang in PDF and/or ePUB format, as well as other popular books in Medicina & Biotecnologia in medicina. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2022
ISBN
9780429939280
Edition
1
Topic
Medicina
Subtopic
Biotecnologia in medicina

1Biologics and Biosimilars 101Principles and Practice

Hong-Guang Xie
Corresponding author: Prof. Hong-Guang Xie
DOI: 10.1201/9780429485626-1

Contents

  1. 1.1Introduction
    1. 1.1.1How to Define the Term Biological Product?
    2. 1.1.2How to Support and Justify the Dose of a New Biological Drug in Labeling?
    3. 1.1.3Who May Use the Marketed Biological Products?
    4. 1.1.4How Does Neonatal Fc Receptor (FcRn) Work?
    5. 1.1.5What Is the Target-Mediated Drug Disposition (TMDD)?
    6. 1.1.6How Does the Nontarget-Related Clearance Work?
    7. 1.1.7How to Integrate All Acquired Information to Guide and Project R&D?
    8. 1.1.8How to Evaluate Cost-Based Value of the Biological Drugs?
  2. 1.2Summary and Future Perspectives
  3. Acknowledgments
  4. References

1.1 INTRODUCTION

The documented history of use of the biological products can be traced back to an earlier vaccine story about Edward Jenner fighting against smallpox in 1796. However, the first therapeutic protein product (Humulin) was approved by the US Food and Drug Administration (FDA) in 1982,1 which was recombinant human insulin developed by Genentech (later licensed to Eli Lilly) through using recombinant DNA technology to synthesize human insulin in bacteria. Since then, biotechnology innovation and scientific breakthroughs have resulted in the creation of a new class of drugs/medicines named biological products that are composed of biologics, biosimilars, and interchangeable biosimilar products. As biotechnology constantly advances, new biological products are ceaseless occurrence in large numbers in the global biopharmaceutical marketplace due to the urgent need of the increased market and clinical access to life-saving medications.
In the past four decades of biological product development, there exist several milestone events worth mentioning. To increase more treatment options and reduce the healthcare cost of biologics through market competition, FDA established the 351(k) pathway, an abbreviated approval process for the biosimilars or interchangeable biosimilar products, as part of the response to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act, signed in law in 2010).2 After that, the first biosimilar filgrastim-sndz (recombinant human granulocyte colony-stimulating factor, or rhG-CSF) and the first interchangeable biosimilar product insulin glargine-yfgn (a long-acting insulin analog for diabetes) were approved by the FDA in 2015 and 2021, respectively (see Table 1.1). Since the approval of Humulin in 1982,1 biologics and their derived biosimilars have gradually dominated new drug research and development (R&D) worldwide. As of 2021, more than 350 biological products have been approved by the FDA.3,4 Clearly, these biological products represent the cutting-edge and frontier of biomedical and biopharmaceutical science research, providing more treatment choices and the most effective means to prevent, treat, and even cure a series of life-threatening diseases and critically ill conditions, some of which currently have no other available medications or therapy regimens (see below for their main indications).
TABLE 1.1 A total of 30 approved biosimilars in relation to their biologics (reference products) as a group of the biological products licensed in the United States (as of July 2021)
BIOLOGIC (REFERENCE PRODUCT)
NAMING OF BIOSIMILARS
TIME OF LICENSURE
Filgrastim (Neupogen)
Filgrastim-sndz (Zarxio)
March 2015
Filgrastim-aafi (Nivestym)
July 2018
Infliximab (Remicade)
Infliximab-dyyb (Inflectra)
April 2016
Infliximab-abda (Renflexis)
May 2017
Infliximab-qbtx (Ixifi)
December 2017
Infliximab-axxq (Avsola)
December 2019
Etanercept (Enbrel)
Etanercept-szzs (Erelzi)
August 2016
Etanercept-ykro (Eticovo)
April 2019
Adalimumab (Humira)
Adalimumab-atto (Amjevita)
September 2016
Adalimumab-adbm (Cyltezo)
August 2017
Adalimumab-adaz (Hyrimoz)
October 2018
Adalimumab-bwwd (Hadlima)
July 2019
Adalimumab-afzb (Abrilada)
November 2019
Adalimumab-fkjp (Hulio)
July 2020
Bevacizumab (Avastin)
Bevacizumab-awwb (Mvasi)
September 2017
Bevacizumab-bvzr (Zirabev)
June 2019
Trastuzumab (Herceptin)
Trastuzumab-dkst (Ogivri)
December 2017
Trastuzumab-pkrb (Herzuma)
December 2018
Trastuzumab-dttb (Ontruzant)
January 2019
Trastuzumab-qyyp (Trazimera)
March 2019
Trastuzumab-anns (Kanjinti)
June 2019
Epoetin-alfa (Epogen)
Epoetin-alfa-epbx (Retacrit)
May 2018
PEGfilgrastim (Neulasta)
Pegfilgrastim-jmdb (Fulphila)
June 2018
Pegfilgrastim-cbqv (Udenyca)
November 2018
Pegfilgrastim-bmez (Ziextenzo)
November 2019
Pegfilgrastim-apgf (Nyvepria)
June 2020
Rituximab (Rituxan)
Rituximab-abbs (Truxima)
November 2018
Rituximab-pvvr (Ruxience)
July 2019
Rituximab-arrx (Riabni)
December 2020
Insulin glargine (Lantus)
Insulin glargine-yfgn (Semglee)a
July 2021
Source: Data from the FDA.6
Notes: Presented in parentheses is a brand name of a certain biologic or biosimilar product for its proprietary nature or exclusivity when patented or registered. The naming of biosimilars is based on the rule of the nonproprietary name of a biologic, followed by four letters, which is convenient for tracking and direct comparison. Among them, (peg)filgrastim is a recombinant human leukocyte growth factor with or without polyethylene glycol (PEG); infliximab is a purified recombinant DNA derived chimeric (human/mouse) IgG mAb that binds and neutralizes TNFĪ±; etanercept is a fusion protein of TNF receptor to the Fc portion of the IgG1 antibody; adalimumab is a fully human mAb targeting TNFĪ±; bevacizumab is an mAb targeting VEGF; trastuzumab is an mAb targeting HER2 receptor; epoetin-alfa is a recombinant human erythropoietin; rituximab is a chimeric mAb targeting CD20 antigen on B-cells; insulin glargine is a recombinant human insulin analog.
a The interchangeable product (a biosimilar itself).
As starting one of a series of the book chapters, this chapter briefly presents some essential knowledge about the biological products for the reader, such as their concise definitions, regulatory policy, justification of labeled dosing, main indications, the fate of the drugs in human body, and cost-effective strategies for their development and utilization.

1.1.1 How to Define the Term Biological Product?

As a new drug class, biologics, biosimilars, and interchangeable biosimilar products are all defined as the drugs or medicines that are manufactured from living organisms and distinguished from those that are from chemical synthesis. By definition, biological products contain an array of complex bioactive macromolecules (such as peptides or proteins) that are naturally occurring substances synthesized in living systems or produced by biotechnology and other cutting-edge technologies. They are frequently isolated from a variety of natural or biological sources, such as humans, animals, microorganisms, and even plants. In fact, as a group of the biological products that are highly similar to each other, biosimilars and their interchangeable products are almost the same as their corresponding biologics (currently defined as biological reference product or originator as a standard control due to the FDA approval first) in nature (at least bioactive principal components), with no clinically meaningful differences from their biologic reference product approved by the FDA first.
The term ā€œbiologicā€ is defined as a bioactive macromolecule that is manufactured in living systems for certain indications of patients. In general, biologics are more expensive than small-molecule chemical drugs because they demonstrate structural complexity and complicated manufacturing process.5 This results in little market competition and almost exclusively market share, both of which are unfavorable conditions for increasing more treatment options and reducing healthcare cost. The high cost of the biologics also ...

Table of contents

  1. Cover Page
  2. Half-Title Page
  3. Title Page
  4. Copyright Page
  5. Contents
  6. Preface
  7. Editor Biographies
  8. Contributors
  9. 1 Biologics and Biosimilars 101: Principles and Practice
  10. 2 Frontiers in Biopharmaceutical Development of Biologics and Biosimilars: Opportunities and Challenges
  11. 3 Biologics and Biosimilars: Research and Development
  12. 4 Vaccines as Biologics in the Era of Pandemic
  13. 5 Therapeutic Delivery Systems for Biologics and Biosimilars
  14. 6 Legislative and Regulatory Pathways for Biosimilars
  15. 7 The Development of Biologics from the Perspective of the Pharmaceutical Industry
  16. 8 The Manufacturing and Quality Assurance Process for Biologics and Biosimilars
  17. 9 Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics of Biological Products
  18. 10 Understanding Variability, Stability, and Immunogenicity of Biosimilars
  19. 11 Expanding the Product Shelf: Taking Biologics and Biosimilars from the Bench to the Bedside
  20. 12 Hydrogel-Based Delivery of Biologics in Cancer and Cardiovascular Diseases: Proof-of-Concept
  21. 13 Clinical Use of Biologics and Biosimilars in Oncology Settings
  22. 14 Monoclonal Antibodies in Cancer Therapeutics
  23. 15 Molecule-Targeted Drugs That Treat Colorectal Cancer
  24. 16 Rising from the Ashes: The Curious Case of the Development of Biologics for the Treatment of Neuroblastoma
  25. 17 Paradigm Shift in Cancer Therapy: Chimeric Antigen Receptor T Cell Therapy
  26. 18 Biologics and Biosimilars Used for Diabetes
  27. 19 Clinical Use of Biologics and Biosimilars in Asthma
  28. 20 Biologics and Biosimilars: Potential Therapeutics for Autoimmune Renal Diseases
  29. 21 Therapeutics of Recombinant Human Clotting Factor VIII (rhFVIII) for Hemophilia A
  30. 22 Complement as New Immunotherapy Target: Past, Present, and Future
  31. 23 Drug Discovery Approaches for Inflammatory Bowel Disease: Antibodies and Biosimilars
  32. 24 Transformative Stem Cell-Based Therapy in Neurological Diseases and Beyond
  33. 25 Biologics and Biosimilars: Clinical Applications and Biomarker Testing
  34. 26 Application of Modeling and Simulation in the Development of Biologics and Biosimilars
  35. 27 Machine Learning Applications in Biologics and Biosimilars: Disruptive Innovation
  36. Index