Biosimilarity: The FDA Perspective
The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other reg...
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| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Boca Raton, FL
CRC Press
[2018]
|
| Edition: | First edition |
| Subjects: | |
| Online Access: | Volltext |
| Summary: | The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy |
| Physical Description: | 1 online resource (436 pages) 79 illustrations, text file, PDF |
| ISBN: | 9781315368344 |
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| spelling | Niazi, Sarfaraz Khan 1949- Verfasser (DE-588)133089851 aut Biosimilarity The FDA Perspective by Sarfaraz K. Niazi First edition Boca Raton, FL CRC Press [2018] © 2017 1 online resource (436 pages) 79 illustrations, text file, PDF txt rdacontent c rdamedia cr rdacarrier The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy MEDICAL / Pharmacology bisacsh Drugs / Generic substitution Pharmaceutical biotechnology / United States Pharmaceutical biotechnology Biosimilar Pharmaceuticals Drug Approval Government Regulation United States Government Agencies Taylor and Francis Sonstige oth https://www.taylorfrancis.com/books/9781315368344 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Niazi, Sarfaraz Khan 1949- Biosimilarity The FDA Perspective MEDICAL / Pharmacology bisacsh Drugs / Generic substitution Pharmaceutical biotechnology / United States Pharmaceutical biotechnology Biosimilar Pharmaceuticals Drug Approval Government Regulation United States Government Agencies |
| title | Biosimilarity The FDA Perspective |
| title_auth | Biosimilarity The FDA Perspective |
| title_exact_search | Biosimilarity The FDA Perspective |
| title_exact_search_txtP | Biosimilarity The FDA Perspective |
| title_full | Biosimilarity The FDA Perspective by Sarfaraz K. Niazi |
| title_fullStr | Biosimilarity The FDA Perspective by Sarfaraz K. Niazi |
| title_full_unstemmed | Biosimilarity The FDA Perspective by Sarfaraz K. Niazi |
| title_short | Biosimilarity |
| title_sort | biosimilarity the fda perspective |
| title_sub | The FDA Perspective |
| topic | MEDICAL / Pharmacology bisacsh Drugs / Generic substitution Pharmaceutical biotechnology / United States Pharmaceutical biotechnology Biosimilar Pharmaceuticals Drug Approval Government Regulation United States Government Agencies |
| topic_facet | MEDICAL / Pharmacology Drugs / Generic substitution Pharmaceutical biotechnology / United States Pharmaceutical biotechnology Biosimilar Pharmaceuticals Drug Approval Government Regulation United States Government Agencies |
| url | https://www.taylorfrancis.com/books/9781315368344 |
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