Biosimilars development strategies : fast to market approaches /
"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. An...
Saved in:
| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Boca Raton :
CRC Press,
2025.
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| Edition: | First edition. |
| Subjects: | |
| Online Access: | Full text (Wentworth users only) |
MARC
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| 100 | 1 | |a Niazi, Sarfaraz, |d 1949- |e author. |1 https://id.oclc.org/worldcat/entity/E39PBJbxJpYQfXMpPJcPpwqmh3 | |
| 245 | 1 | 0 | |a Biosimilars development strategies : |b fast to market approaches / |c by Sarfaraz K. Niazi. |
| 250 | |a First edition. | ||
| 263 | |a 2407 | ||
| 264 | 1 | |a Boca Raton : |b CRC Press, |c 2025. | |
| 300 | |a 1 online resource | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a All About Biosimilars -- Product Type and Selection Strategies -- Development Master Plan -- Optimization of Cost of Goods -- Strategic Understanding for Biosimilars Future -- Repurposing Biosimilars. | |
| 520 | |a "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"-- |c Provided by publisher. | ||
| 545 | 0 | |a 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. | |
| 588 | |a Description based on print version record and CIP data provided by publisher; resource not viewed. | ||
| 650 | 0 | |a Drugs |x Design. | |
| 650 | 1 | 2 | |a Biosimilar Pharmaceuticals |
| 650 | 1 | 2 | |a Drug Development |
| 650 | 2 | 2 | |a Drug Design |
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