Biosimilars: Design and Analysis of Follow-on Biologics

by Shein-Chung Chow

Book Overview

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 manufacturing process and the structures of biosimilar products.

Written by a top biostatistics...

• Format: Paperback
• Language: English
• ISBN: 0367379724
• ISBN13: 9780367379728
• Release Date: October 2019
• Publisher: CRC Press
• Length: 444 Pages
• Weight: 1.37 lbs.
• Dimensions: 0.9" x 6.1" x 9.2"