Sarfaraz K. Niazi

Opinion author

Sarfaraz K. Niazi, Ph.D., is an adjunct professor at the University of Illinois and University of Houston, CEO of RNA Therapeutics and CTO of ABYOLO, companies developing biological drugs. ABYOLO is specifically focused on biosimilars. He also serves as an advisor to the FDA, the EMA, the MHRA and several heads of state in creating rational regulatory guidelines and introducing new technologies to make lifesaving biological products accessible across the globe. Niazi established the first biosimilar company in the US. and secured several FDA approvals. He has written 50+ books, 150+ papers, given hundreds of talks, and secured 250+ U.S. patents made royalty-free to all, except those developed at the request of the U.S. government. He is an editor of several prominent journals and a patent law practitioner offering pro bono services to developing country scientists, securing hundreds of U.S. patents for them. He is a recipient of dozens of scholarly fellowships, an inductee into the U.S. Hall of Fame, having secured over $500 million to develop biosimilars and a recipient of many civil awards. His current work involves developing biosimilar gene therapy products, including vaccines.

Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue.