Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.
WHO Biosimilar Guidance Is Based on Weak ScienceApril 11th 2020
The World Health Organization’s guidance for the development and approval of biosimilars is based on faulty science and reasoning, and it represents a hazard to the safety of patients that must be corrected, according to Sarfaraz K. Niazi, PhD.
A Critical Analysis of the Final Guidance on Demonstrating Interchangeability of a Biosimilar With Its Reference ProductMay 21st 2019
The final guidance on interchangeability resolves some issues, creates many new issues and inquiries, and offers a path—albeit not a clear one—that is filled with scientific and clinical challenges.