Biosimilars and Interchangeable Biologics
eBook - ePub

Biosimilars and Interchangeable Biologics

Strategic Elements

  1. 599 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Biosimilars and Interchangeable Biologics

Strategic Elements

About this book

What's the Deal with Biosimilars?

Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development.

Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets.

Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

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Yes, you can access Biosimilars and Interchangeable Biologics by Sarfaraz K. Niazi in PDF and/or ePUB format, as well as other popular books in Medicine & Business General. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2018
Print ISBN
9781498743471

Table of contents

  1. Cover
  2. Half Title
  3. Title Page
  4. Copyright Page
  5. Dedication
  6. Table of Contents
  7. List of figures
  8. List of tables
  9. Preface
  10. Acknowledgments
  11. Introduction
  12. Author
  13. 1 Introduction to biosimilar and interchangeable products
  14. 2 Intellectual property issues for biosimilars
  15. 3 European regulatory guidance
  16. 4 EMA-approved biosimilars
  17. 5 FDA regulatory guidance
  18. 6 ROW regulatory guidance
  19. 7 U.S. commercialization
  20. 8 Global commercialization
  21. 9 Quality and lifecycle management
  22. Appendix A: A brief history of biosimilars
  23. Appendix B: Patent expiry dates for potential biosimilar products
  24. Appendix C: Biological products licensed in the United States
  25. Index