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# Create Unified Reference-Anchored Framework for Follow-Ons
- URL: https://www.fdaweb.com/create-unified-reference-anchored-framework-for-follow-ons/
- Published: 2026-08-25T12:00:00.000Z
- Updated: 2026-09-14T12:05:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161678

Washington State University College of Pharmacy and Pharmaceutical Sciences affiliate professor **Sarfaraz Niazi** is petitioning FDA to extend the product-level, evidence-scaled logic reflected in its therapeutic-equivalence and biosimilar programs into a unified reference-anchored framework for follow-on human drugs and biological products. The [petition](https://downloads.regulations.gov/FDA-2026-P-9683-0001/attachment%5F2.pdf?ref=fdaweb.com) says the framework would not collapse distinct statutory standards, would not create automatic approval or substitution, and would not displace a patent or statutory exclusivity. “It would establish a common scientific method for determining when reliance on an already approved reference product is justified,” it says, “what additional evidence is actually necessary, and when abbreviated reliance must stop.”

Niazi specifically asks that FDA:

- amend or supplement the agency’s therapeutic equivalence policy;
- establish a cross-center, reference-anchored follow-on framework;
- permit product-specific demonstrations for all legally eligible biological products;
- replace routine study sequences with a residual uncertainty standard;
- require a prospective Equivalence Justification Package;
- separate approval by reliance from substitution policy;
- use existing authority fully and identify statutory gaps explicitly; and
- establish a pilot and publish learning.