Niazi, Sarfaraz K. <br/><br/>
Biosimilars development strategies :  fast to market approaches /  English. 
by Sarfaraz K. Niazi. 
 - 1st. 
 - Boca Raton :  CRC Press Taylor & Francis Group,  2025. 
 - viii, 187 p. ;  24 cm. 
<br/><br/>Includes bibliographical references and index. 
<br/><br/>All About Biosimilars -- Product Type and Selection Strategies -- Development Master Plan -- Optimization of Cost of Goods -- Strategic Understanding for Biosimilars Future -- Repurposing Biosimilars. 
<br/><br/> "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. 
<br/><br/><label>ISBN: </label>
<br/><br/><label>LCCN: </label>2024003718 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Biosimilar Pharmaceuticals<br/>Drug Development<br/>Drug Design
<br/><br/><label>Dewey Class. No.: </label>615.19  / NIA.S 
<br/><br/><label>National Library of Medicine Call No.: </label>QV 241