TY  - BOOK
AU  - Niazi,Sarfaraz K.
TI  - Biosimilars development strategies: fast to market approaches 
U1  - 615.19 23
PY  - 2025///
CY  - Boca Raton
PB  - CRC Press Taylor & Francis Group
KW  - Biosimilar Pharmaceuticals
KW  - Drug Development
KW  - Drug Design
N1  - Includes bibliographical references and index; All About Biosimilars -- Product Type and Selection Strategies -- Development Master Plan -- Optimization of Cost of Goods -- Strategic Understanding for Biosimilars Future -- Repurposing Biosimilars
N2  - "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"-- Provided by publisher
ER  -