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- 198 pages
- English
- ePUB (mobile friendly)
- Only available on web
eBook - ePub
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About This Book
After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author's hands-on experience.
Features:
- Describes the emergence of biosimilars since the first publication of the recombinant engineering patent, as well as a listing of all approved recombinant products, their patent expiry and their adoption across the globe.
- Provides a better understanding of the safety and efficacy of approved biosimilars.
- Global approval requires accommodating guidelines and detailed planning to avoid redundancy as well as high costs. The basic expectations of the agencies are presented here.
- Presents a detailed analysis of all EU and FDA-approved products with a comparative analysis.
- Renowned author and entrepreneur in the field of drug discovery and production.
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Yes, you can access Biosimilars Development Strategies by Sarfaraz K. Niazi in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.
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Table of contents
- Cover
- Half Title
- Title Page
- Copyright Page
- Table of Contents
- Preface
- Author
- Chapter 1 All About Biosimilars
- Chapter 2 Product Type and Selection Strategies
- Chapter 3 Development Master Plan
- Chapter 4 Optimization of Cost of Goods
- Chapter 5 Strategic Understanding for Biosimilars Future
- Chapter 6 Repurposing Biosimilars
- Index