Sarfaraz K. Niazi

# Sarfaraz K. Niazi: A Trailblazer in Biosimilars and Biopharmaceuticals

## **Biography**

Dr. Sarfaraz K. Niazi is a distinguished pharmaceutical scientist, entrepreneur, and inventor who has revolutionized the biosimilar industry and established himself as one of the most influential figures in biopharmaceutical development. Born on July 10, 1949, in Lucknow, India, Niazi's journey from a pharmacy student to a globally recognized expert demonstrates his exceptional commitment to making life-saving medications accessible worldwide.

## **Educational Foundation**

Niazi's academic journey began at the University of Karachi, where he earned his Bachelor of Science degree in pharmacy in 1969. Following his family's migration to the United States in 1970, he pursued advanced studies at Washington State University, obtaining his Master of Science degree in pharmaceutical sciences in 1971. He completed his doctorate in pharmaceutical sciences at the University of Illinois at Chicago in 1974, establishing the foundation for his groundbreaking career.

## **Career Highlights**

### **Academic Excellence**
From 1972 to 1988, Niazi served as faculty at the University of Illinois at Chicago College of Pharmacy, progressing from instructor to tenured associate professor. He currently holds adjunct professor positions at both the University of Illinois and the University of Houston, continuing to share his expertise with the next generation of pharmaceutical scientists.

### **Industry Leadership**
Niazi's corporate career included a significant tenure at Abbott Laboratories from 1988 to 1995, where he served as Director of Technical Affairs. His entrepreneurial spirit led him to establish Pharmaceutical Scientist, Inc. in 1997, followed by the founding of Therapeutic Proteins, Inc. in 2003. Most recently, he serves as CEO of RNA Therapeutics, Inc., and Chicago University, Inc..

### **Pioneering Achievements**

Dr. Niazi's most notable contribution to the pharmaceutical industry is establishing the first biosimilar company in the United States. His company, Therapeutic Proteins, later known as Adello Biologics, successfully secured multiple FDA approvals and raised over $500 million in funding. He is widely credited with coining the term "biosimilar" and developing the regulatory framework that enabled these life-saving alternatives to expensive biologic drugs.

### **Regulatory Impact**
Niazi's influence extends beyond entrepreneurship to regulatory guidance. He has served as an advisor to the FDA, EMA, and other regulatory agencies worldwide. His citizen petitions have led to significant policy changes, including the FDA's withdrawal of its pivotal biosimilar products testing guideline - a rare occurrence that demonstrates his scientific authority.

## **Notable Recognition**

### **Forbes Magazine Features**
Niazi has been prominently featured on Forbes Magazine covers multiple times, earning the designation as **"The Most Interesting Man Revolutionizing the Health World"** in 2014. Forbes has also recognized his innovative contributions with articles titled "Scientist Invented a New Pathway To Approve Biosimilars, And The FDA Is Listening" in 2019.

### **Awards and Honors**
- **Sitara-i-Imtiaz** (2012): Pakistan's highest civil award for contributions to engineering sciences
- **Inductee, Chicago Hall of Entrepreneurs** (2015)
- **University of Illinois Alumni of the Year**
- **Fellowships**: Royal Society of Biology, Pakistan Academy of Medical Sciences, American Society of Clinical Biochemistry

## **Literary Contributions**

Beyond his scientific achievements, Niazi has made significant contributions to literature through his translations of classical Urdu and Persian poetry. He published the first complete English translation of the ghazals (love poems) of Mirza Ghalib in 2002, making this treasured poetry accessible to English-speaking audiences worldwide. His work includes multiple volumes of Ghalib's poetry translations and Persian love poems.

### **Voice of America**
From 2008 to 2016, Niazi served as a radio host for Voice of America, where he broadcast explications of Ghalib's poetry every Sunday, sharing his love for classical literature with international audiences.

## **Intellectual Property Portfolio**

Niazi holds over 100 U.S. patents spanning diverse fields including bioprocessing, drug delivery systems, wine aging, and automobile safety. As a registered Patent Agent with the U.S. Patent and Trademark Office since 2002, he has prosecuted over 500 patents and provides pro bono services to scientists in developing countries.

## **Current Focus: mRNA Therapeutics**

Dr. Niazi's current work centers on mRNA therapeutics, positioning him at the forefront of post-pandemic medical innovation. His comprehensive book "mRNA Therapeutics: Fast-to-Market Strategies" represents the most complete treatise on nucleic acid therapeutic products. He envisions mRNA technology as a paradigm shift that will enable treatment of previously untreatable diseases, including autoimmune disorders like diabetes, Parkinson's disease, and Alzheimer's disease.

## **Global Impact**

Through his extensive body of work—comprising over 50 books, 100+ research papers, and hundreds of speaking engagements worldwide—Niazi has demonstrated an unwavering commitment to making essential medications accessible globally. His vision to "invent and reinvent biologicals" continues to drive innovation in pharmaceutical sciences, with particular focus on reducing development costs and regulatory barriers for biosimilar products.

Dr. Sarfaraz K. Niazi's multifaceted career exemplifies the intersection of scientific excellence, entrepreneurial vision, and humanitarian purpose, making him a true pioneer in modern pharmaceutical sciences and a champion of global health accessibility.