Professor Sarfaraz K. Niazi Secures First-Ever FDA Acceptance to Waive Clinical Efficacy Studies for Monoclonal Antibody Biosimilars

CHICAGO, Sept. 1, 2025 /PRNewswire/ -- In a groundbreaking milestone for global healthcare and pharmaceutical innovation, Professor Sarfaraz K. Niazi, Adjunct Professor at the University of Illinois at Chicago and founder of multiple biopharmaceutical enterprises, has secured the first-ever FDA acceptance to waive clinical efficacy studies (CESs) for monoclonal antibody biosimilars. This decision fundamentally redefines how biological drugs will be developed, approved, and made affordable for patients worldwide.

For decades, CESs have been a central — and costly — component of biosimilar approval, despite their inability ever to demonstrate meaningful failure outcomes. In numerous citizen petitionsⁱ to the FDA and dozens of peer-reviewed publications advising the FDA,ⁱⁱ Professor Niazi has persistently argued that CESs add no scientific value to biosimilar evaluation, as analytical similarity and immunogenicity studies are sufficient to confirm biosimilarity. His advocacy has now culminated in the FDA's acceptance of this evidence-based paradigm shift.

The First Case: Stelara Biosimilar

Professor Niazi's biosimilar application for Stelara (ustekinumab) will be the first filed with the FDA without requiring any clinical testing, marking a precedent-setting regulatory breakthrough.

Global Impact on Drug Affordability

The removal of CES requirements is expected to:

• Reduce biosimilar development costs by over 90%
• Accelerate approval timelines by more than 70%
• Empower small- and mid-sized companies to enter the biosimilar market, where entry had previously been limited to resource-rich pharmaceutical giants
• Spur competitive pricing that mirrors the trajectory of generic small-molecule drugs, delivering widespread affordability to patients

This decision aligns the FDA with the European Medicines Agency (EMA) and the UK's MHRA, which have already taken steps in line with Niazi's recommendations. With harmonization across regulatory jurisdictions, the pathway to global biosimilar approvals becomes clearer than ever before.

A Career of Firsts

Professor Niazi is no stranger to pioneering change. His contributions include:

• Creating the term "biosimilars," establishing the first US biosimilar company, and securing FDA approval of multiple biosimilars.
• Creating the first effective treatment of Alzheimer's disease by improving its entry across the blood-brain barrier.
• Securing the US Congress approval of a waiver of animal testing of biological drugs after publishing his thesis in Science Magazine.ⁱⁱⁱ
• Challenging the Nobel Prize Committee for the 2024 Chemistry Prize,^iv and pointing out the mistake in publishing a wrong paper in Science Magazine on the topic of artificial intelligence.^v

A Historic Turning Point

"This is not just my victory," said Professor Niazi. "This is a victory for science, for reason, and most importantly, for patients who deserve affordable access to biological medicines. The FDA's acceptance ushers in a new era where innovation is not held hostage by outdated testing requirements. It will fundamentally reshape the economics of biosimilars and expand access globally."

As regulators worldwide continue to align, today's decision by the FDA marks one of the most historic turning points in modern drug development — where rigorous science, patient access, and cost reduction converge.

Professor Niazi is now encouraging mid-sized and small generic companies to enter the field of biosimilars, as the cost of their development will be readily affordable. This will allow for substantial price reduction, the primary goal of biosimilars, and make them affordable to the majority of global patients.

Pharmaceutical Scientist, Inc., is a regulatory advisory to biopharmaceutical companies, the regulatory agencies, and several heads of state, as well as the US Senate and the White House

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ⁱ https://www.regulations.gov/search?filter=fda%20niazi.
ⁱⁱ Niazi S. Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars. Drug Des Devel Ther. 2022 Aug 24;16:2803-2815. https://www.dovepress.com/scientific-rationale-for-waiving-clinical-efficacy-testing-of-biosimil-peer-reviewed-fulltext-article-DDDT .; Niazi SK. Biosimilars adoption: Recognizing and removing the roadblocks. Clinicoecon Outcomes Res.2023;15:281–294; https://www.dovepress.com/biosimilars-adoption-recognizing-and-removing-the-roadblocks-peer-reviewed-fulltext-article-CEOR; Niazi, S.K. Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies. Pharmaceuticals 2025, 18, 779. https://doi.org/10.3390/ph18060779
ⁱⁱⁱ Niazi SK. End animal testing for biosimilar approval. Science. 2022 Jul 8;377(6602):162-163. (https://www.science.org/doi/10.1126/science.add4664)
^iv https://www.prnewswire.com/news-releases/professor-niazi-challenges-the-2024-chemistry-nobel-prize-that-the-3d-protein-structure-cannot-be-predicted-refuting-claims-of-rosetta-and-alphafold-302425864.html
^v https://www.science.org/doi/10.1126/science.adv9817#elettersSection

SOURCE Pharmaceutical Scientist, Inc.