FDA Issues Landmark Biosimilar Guidance Incorporating Regulatory Reforms Advised by Professor Niazi: Further Cutting Development Costs by Up to 50%

WASHINGTON, March 10, 2026 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)¹, a sweeping guidance that codifies multiple regulatory modernization proposals first advanced by Professor Sarfaraz K. Niazi, pharmaceutical scientist, Adjunct Professor at the University of Illinois Chicago (College of Pharmacy), and regulatory advisor to the FDA, EMA, and MHRA. The guidance is projected to reduce biosimilar development costs by as much as 50 percent — roughly $20 million per program² — opening a market long dominated by large pharmaceutical firms to smaller biotechnology companies.

What the FDA Adopted — and What Niazi Proposed First

Each major element of the new guidance corresponds to a reform Professor Niazi advocated in peer-reviewed literature and formal citizen petitions to the FDA:

1. Removal of Comparative Clinical Efficacy Studies
   Niazi published the scientific rationale for eliminating costly confirmatory efficacy trials, demonstrating they yield little additional information once analytical and pharmacokinetic similarity are established.^3,4,5 The FDA has now formally issued guidance waiving these studies, and Niazi received the first FDA acceptance of a clinical efficacy study waiver for a monoclonal antibody. (Biosimilar Development, 2025: https://www.biosimilardevelopment.com/doc/fda-issues-formal-guideline-waiving-clinical-efficacy-studies-for-biosimilars-confirming-professor-niazi-s-year-campaign-0001)
2. Removal of Animal Toxicology Testing and Tier-Based Analytical Similarity
   In a 2022 paper in Science, Niazi called for ending animal testing in biosimilar approval pathways.⁶ The new guidance eliminates tiered analytical similarity assessments and removes animal toxicology requirements as standard studies.
3. Removal of Immunogenicity Testing Requirements
   Niazi published a critical analysis arguing that comparative immunogenicity studies are scientifically redundant for highly similar biologic products.⁷ This position is now reflected in the FDA’s updated framework.
4. Alternatives to Interchangeability Status
   Niazi’s 2022 paper in the Journal of Clinical Pharmacy and Therapeutics urged the FDA and Congress to eliminate the two-class biosimilar distinction, proposing alternatives to full interchangeability designation.⁸ Updated interchangeability guidance issued in 2024 reflects these arguments.⁹
5. Acceptance of Non-U.S. Comparator Clinical Data
   Niazi’s citizen petitions (FDA Docket FDA-2018-P-1876) formally proposed allowing data from non-U.S. comparator studies when scientifically justified, eliminating the need for duplicative pharmacokinetic studies.¹⁰ This is now accepted FDA policy under the new guidance.
6. Simplified IND Framework and Streamlined CMC Requirements
   Niazi’s publications consistently advocated for an IND framework tailored to biosimilar programs and greater reliance on modern analytical characterization rather than clinical confirmation.^3,11 These principles are codified in the new guidance.

Market Implications

Biologics constitute approximately 5% of U.S. prescriptions yet roughly 51% of total drug spending². The global biosimilars market reached ~$30 billion in 2024¹² and could generate over $180 billion in U.S. healthcare savings¹³ in coming years. Biosimilar development has historically cost $100–$200 million per product, limiting participation to large multinational firms.

“If regulatory science evolves toward analytical characterization and pharmacokinetic comparison rather than extensive clinical trials, development costs will drop dramatically,” said Niazi. “That creates opportunities for smaller biotechnology companies to enter the market. Large pharmaceutical companies may gradually withdraw from biosimilars as profit margins compress, while specialized manufacturers expand participation because lower development costs make entry feasible.”

Niazi’s 2022 advisory paper in Expert Opinion on Biological Therapy outlined precisely this market evolution.¹¹

Two Unresolved Issues Remain

Despite the landmark reforms, Professor Niazi identifies two outstanding policy gaps that, if addressed, would further accelerate biosimilar competition:

USP Standardized Biologic Release Specifications. Niazi has formally petitioned the FDA to authorize the United States Pharmacopeia to develop standardized product specifications for biologics, which would eliminate the need for expensive reference-product comparisons in every biosimilar program.¹⁴ This reform remains pending.

Patent Doping. Originator manufacturers file cascades of secondary patents — sometimes dozens per product — to delay biosimilar entry even after primary patent expiration. Niazi’s 2024 analysis documented how contradictory USPTO rulings on double patenting have undermined generic and biosimilar competition.¹⁵ Congress and the USPTO have yet to act on corrective measures.

About Professor Sarfaraz K. Niazi

Professor Sarfaraz K. Niazi is a pharmaceutical scientist and Adjunct Professor at the University of Illinois Chicago.  He has served as a regulatory advisor to the FDA, EMA, and MHRA and has authored scores of peer-reviewed publications and citizen petitions in biosimilar regulatory science. His proposals for modernizing biosimilar approval pathways have been adopted by the FDA across successive guidance revisions spanning 2022–2026.

Media Contact
Office of Scientific Communications | Washington, D.C. | niazi@niazi.com

References

1. US Food and Drug Administration. New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4). FDA; 2026. https://www.fda.gov/media/119278/download.
2. Reuters. FDA to ease testing rules to speed biosimilar approvals. March 9, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/fda-ease-testing-rules-speed-biosimilar-approvals-bloomberg-news-reports-2026-03-09/.
3. Niazi SK. Scientific rationale for waiving clinical efficacy testing of biosimilars. Drug Des Devel Ther. 2022;16:2803-2815. doi:10.2147/DDDT.S378813.
4. Niazi SK. Support for removing pharmacodynamic and clinical efficacy testing of biosimilars. Clin Pharmacol Drug Dev. 2023;12(12):1134-1141. doi:10.1002/cpdd.1349.
5. Niazi SK. Scientific justification and policy recommendations to the US FDA for waiving comparative efficacy studies. Pharmaceutics. 2025;18(6):779. doi:10.3390/ph18060779.
6. Niazi SK. End animal testing for biosimilar approval. Science. 2022;377(6602):162-163. doi:10.1126/science.add4664.
7. Niazi SK. A critical analysis of the FDA guidance on clinical immunogenicity. Available at: https://niazi.org/a-critical-analysis-of-the-fda-guidance-on-clinical-immunogenicity/.
8. Niazi SK. No two classes of biosimilars: urgent advice to the US Congress and the FDA. J Clin Pharm Ther. 2022;47(9):1352-1361. doi:10.1111/jcpt.13735.
9. US Food and Drug Administration. Considerations in Demonstrating Interchangeability With a Reference Product (Update). FDA; 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-update.
10. Niazi Citizen Petitions to FDA (FDA-2018-P-1876 and others). https://www.regulations.gov/search?filter=fda%20niazi%20biosimilar.
11. Niazi SK. Biosimilars: a futuristic fast-to-market advice to developers. Expert Opin Biol Ther. 2022;22(6):709-716. doi:10.1080/14712598.2022.2035212.
12. Alira Health. 2025 Global Biosimilars Report. Alira Health; 2025. https://alirahealth.com/education-hub/2025-global-biosimilars-report/.
13. IQVIA Institute. Biosimilars in the United States 2023-2027. IQVIA; 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2023-2027.
14. Niazi SK. Advice to the US FDA to allow US Pharmacopeia to create biological product specifications to remove side-by-side analytical comparisons. Pharmaceutics. 2024;16(8):1013. doi:10.3390/pharmaceutics16081013.
15. Niazi SK. Contradicting rulings of the US patent office on double patenting jeopardize generic and biosimilar drugs. Pharm Patent Anal. 2024;13(4-6):95-103. doi:10.1080/20468954.2025.2459582.

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