Biosimilars —— Design and Analysis of Follow-on Biologics

----- 生物仿制药：设计与分析

ISBN: 9781466579699 出版年：2013 页码：432 Chow, Shein-Chung CRC Press

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manuf