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Synopsis
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.
"synopsis" may belong to another edition of this title.
About the Author
Sarfaraz K Niazi, Ph.D., is an Adjunct Professor at the University of Illinois. He has authored 60+ major books, 100+ research papers, and 100+ patents, mainly in bioprocessing. He has hands-on experience establishing biopharmaceutical projects, from concept to market, including setting up the first biosimilar company in the US and leading to several FDA approvals. He serves as an advisor to several regulatory agencies, including the FDA.
"About this title" may belong to another edition of this title.
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Biosimilars Development Strategies (Paperback)
Published by
Taylor & Francis Ltd, London, 2025
ISBN 10: 1032519584
ISBN 13: 9781032519586
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Paperback. Condition: new. Paperback. 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. Provides an update on the status of biosimilars and a perspective for the next decade. How biosimilars are developed in the future will include many AI-based features to establish structural similarity that will prevent the need for most other testing, including detailed analytical assessment and clinical pharmacology testing. This item is printed on demand. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. Seller Inventory # 9781032519586
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Biosimilars Development Strategies : Fast to Market Approaches
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Biosimilars Development Strategies: Fast to Market Approaches
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Biosimilars Development Strategies
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Biosimilars Development Strategies
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Biosimilars Development Strategies
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Biosimilars Development Strategies
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Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. 198 pp. Englisch. Seller Inventory # 9781032519586
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Biosimilars Development Strategies : Fast to Market Approaches
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Biosimilars Development Strategies: Fast to Market Approaches
Published by
Taylor & Francis Ltd, 2025
ISBN 10: 1032519584
ISBN 13: 9781032519586
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