TY  - BOOK
AU  - Niazi,Sarfaraz K.
ED  - Taylor and Francis.
TI  - Biosimilarity: The FDA Perspective 
SN  - 9781315368344
AV  - RS67.U6 N539 2018
U1  - 615.10973 
PY  - 2018///]
CY  - Boca Raton, FL
PB  - CRC Press
KW  - Drugs
KW  - Generic substitution
KW  - Pharmaceutical biotechnology
KW  - United States
KW  - Biosimilar Pharmaceuticals
KW  - Drug Approval
KW  - Government Regulation
KW  - United States Government Agencies
KW  - MEDICAL / Pharmacology
KW  - bisacsh
KW  - Electronic books
N1  - Includes bibliographical references and index; Current Status of Biosimilar Biological Products. The FDA Position. Biosimilarity Tetrahedron. Analytical and Functionality Similarity. Non-clinical Assessment. Clinical Pharmacology Assessment. Clinical Studies. Interchangeability Status. Comprehensive Presentation; Also available in print format
N2  - 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
UR  - https://www.taylorfrancis.com/books/9781315368344
ER  -