Professor Sarfaraz K. Niazi Files Landmark Citizen Petition Urging the FDA to Modernize Biosimilar Approval Pathways and Transform Global Access to Biological Medicines

CHICAGO, Dec. 8, 2025 /PRNewswire/ -- Professor Sarfaraz K. Niazi, Ph.D., a leading authority in pharmaceutical sciences and internationally recognized biosimilars expert, has filed a major Citizen Petition with the U.S. Food and Drug Administration (FDA) calling for sweeping regulatory and scientific reforms that would dramatically reduce the cost, duration, and complexity of biosimilar development—ushering in a new era of global access to life-saving biological drugs.

Professor Niazi had been able to secure many changes in the regulatory guidelines for biosimilars, including removing tiered analytical testing, removing animal toxicology testing, waiving immunogenicity testing, and, recently, waiving clinical efficacy studies. However, several hurdles remain to the approval of biosimilars, as presented in this Citizen Petition filed by Professor Niazi.

The petition, titled "Regulatory and Scientific Reforms to Accelerate Biosimilar Approval and Access," outlines a comprehensive set of reforms that the FDA can implement immediately under existing statutory authority. These changes focus on removing unnecessary clinical testing, modernizing analytical requirements, addressing patent barriers, and harmonizing global approval standards.

Key Proposals include:

• Standardizing analytical testing through U.S. Pharmacopeia Biological Product Specifications. This allowance to use USP data will remove the need to secure reference product samples.
• Automatically designating all FDA-approved biosimilars as interchangeable.
• Replacing routine immunogenicity studies with validated aggregate-removal technologies.
• Eliminating pharmacokinetic studies for intravenous, ocular, or tissue-specific products.
• Removing the four-letter suffix from biological product names.
• Allowing global reference products without bridging studies.
• Addressing double-patenting barriers.
• Expanding global regulatory harmonization.

Professor Niazi emphasized that these reforms could save millions in development costs per product, reduce development timelines by over a year, and expand patient access to affordable biological medicines worldwide.

Public Comment Invitation:

Readers are encouraged to submit comments supporting this petition at:

https://www.regulations.gov/document/FDA-2025-P-6763-0001

Media Contact:

Professor Sarfaraz K. Niazi, Ph.D., Adjunct Professor, University of Illinois College of Pharmacy, Email: niazi@niazi.com; Phone: 312-297-0000

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