FDA Issues Formal Guideline Waiving Clinical Efficacy Studies for Biosimilars, Confirming Professor Niazi's 15-Year Campaign to Cut Biologic Drug Costs

A Landmark Regulatory Shift Validates Professor Sarfaraz K. Niazi's Vision to Make Biologics as Affordable as Generics

CHICAGO, Oct. 29, 2025 /PRNewswire/ -- In a historic move reshaping global drug development, the U.S. Food and Drug Administration (FDA) today issued a formal guideline eliminating the requirement for clinical efficacy studies (CES) in biosimilar approvals, a change long championed by Professor Sarfaraz K. Niazi, Ph.D., Adjunct Professor at the University of Illinois.

https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs?utm_medium=email&utm_source=govdelivery

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product-updated-recommendations?utm_medium=email&utm_source=govdelivery

This official FDA action marks the culmination of a fifteen-year scientific and regulatory effort led by Professor Niazi, who has consistently argued that CES add no meaningful value to biosimilar assessment because they cannot fail once analytical and functional similarity is proven.

"Today's FDA guideline finally validates what I have been saying for years — that clinical efficacy studies are scientifically redundant, wasteful, and unethical when similarity is already proven. This moment will change the economics of biologic drugs forever," said Professor Niazi.

A 15-Year Journey to Transform Biologic Regulation
Over the past decade and a half, Professor Niazi has engaged in an unprecedented campaign of over 50 peer-reviewed publications, multiple citizen petitions, and direct dialogues with FDA leadership. His mission: to demonstrate that biosimilars could be approved through rigorous analytical and functional testing alone — without costly and repetitive human efficacy trials.

Although his own biosimilar products previously received CES waivers, skepticism persisted across the biopharmaceutical industry. The FDA's formal issuance of this guideline today removes all doubt, confirming Professor Niazi's position and ushering in an era where biosimilars can be developed at near-generic cost.

Regulatory Reforms Now Incorporated in the FDA Framework
The new FDA guidance document enshrines a series of reforms first proposed by Professor Niazi, transforming the Biologics Price Competition and Innovation Act (BPCIA) landscape:

These reforms collectively reduce biosimilar development costs by over 90 percent, aligning them with the economics of small-molecule generics and dramatically accelerating patient access to advanced biologics.

From "Biogenerics" to Global Access
Professor Niazi's legacy in biosimilars is foundational: he coined the term "biosimilar," founded the first U.S. biosimilar company, and authored the first book on the subject. Initially referring to them as biogenerics, he later adopted the term biosimilars at the FDA's request — a term now synonymous with high-quality, low-cost biologics.

"The issuance of this guideline makes biosimilars truly biogeneric. I encourage all generic-drug companies to enter this field — the science is proven, the regulatory path is open, and the humanitarian need is undeniable," said Niazi.

The Road Ahead
Professor Niazi is now focusing on additional structural reforms to remove remaining inefficiencies in the biologic regulatory ecosystem, including:

• Replacing monographs with release specifications, ending the need to purchase reference products for comparison.
• Legislation to end double patenting of biologic drugs, promoting genuine innovation.
• Global harmonization of biosimilar standards to ensure affordability and access for patients in all economies.

Despite outreach to major biosimilar associations, few have joined his call — perhaps, he notes, because this transformation reduces dependency on traditional intermediaries and returns scientific control to developers and regulators.

About Professor Sarfaraz K. Niazi
Professor Sarfaraz K. Niazi, Ph.D. is an Adjunct Professor at the University of Illinois College of Pharmacy, a leading voice in biosimilar and biologic drug reform, and a recognized advisor to the FDA, EMA, MHRA, and U.S. Senate. With more than 100 books and scientific publications, his contributions span biosimilars, mRNA vaccines, protein engineering, and continuous manufacturing. His lifelong mission is to make advanced therapeutics accessible and affordable for all patients.

Media Contact:
Professor Sarfaraz K. Niazi, Ph.D.
Email: [email protected]
Website: www.niazi.com

SOURCE: Professor Sarfaraz K. Niazi