Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues

by Sarfaraz K. Niazi

More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulatory wrinkles yet to be ironed out, generic or similar biological products are soon to become a reality...

• Format: Paperback
• Language: English
• ISBN: 0367454815
• ISBN13: 9780367454814
• Release Date: December 2019
• Publisher: CRC Press
• Length: 584 Pages
• Weight: 2.21 lbs.
• Dimensions: 1.2" x 7.0" x 10.0"