The petition requests that the FDA broaden the scientific principles supporting generics and biosimilars to encompass all eligible FDA-approved drugs and biological products. This initiative has the potential to foster competition for some of the most expensive therapies globally once patent and exclusivity protections expire, thereby eliminating barriers to market entry.
SPOKANE, Wash., Aug. 25, 2026 /PRNewswire/ — Professor Sarfaraz K. Niazi of the College of Pharmacy and Pharmaceutical Sciences at Washington State University has submitted a Citizen Petition to the U.S. Food and Drug Administration, requesting the establishment of a new and unified scientific framework that could potentially revolutionize the development process for follow-on versions of FDA-approved medications.
The petition, entitled “Request to Establish a Unified Reference-Anchored Equivalence Framework for Follow-On Human Drug and Biological Products,” respectfully requests that the Food and Drug Administration (FDA) expand the scientific rationale presently utilized for generic drugs, and gradually for biosimilars, to encompass the full range of FDA-approved human pharmaceuticals and biological products, whenever existing legislation permits such an extension.
The proposal may have notably profound implications for high-cost biological and advanced therapeutic products, encompassing monoclonal antibodies, complex biological medicines, vaccines, gene therapies, nucleic-acid products, lipid-nanoparticle products, plasma-derived products, and, where scientifically justifiable, specific cellular therapies.
The primary concern of the petition is as follows: If a medicine approved by the FDA has been manufactured consistently for commercial purposes, its clinically relevant characteristics can be reliably evaluated, and a second manufacturer can demonstrate that their product shows no clinically meaningful difference from the reference product, then why is it customary to mandate the second manufacturer to repeatedly perform development studies that offer minimal or no further scientific insight?
Niazi calls the proposed principle “reference-anchored equivalence.”
Under the proposed framework, the Food and Drug Administration (FDA) would refrain from categorically declaring all medicines as copyable, nor would it grant automatic approval. Instead, each proposed follow-on product must undergo a thorough, product-specific scientific and legal evaluation. The manufacturer is required to demonstrate that the reference product can be appropriately sampled, that clinically significant characteristics can be measured with sufficiently sensitive methods, that relevant functions and exposure levels are comparable, and that any new risks introduced by the follow-on manufacturer’s process are independently assessed.
When persistent uncertainty of scientific findings remains, the Food and Drug Administration (FDA) shall maintain complete authority to require additional pharmacokinetic, pharmacodynamic, immunogenicity, nonclinical, or clinical investigations. Nevertheless, if such studies do not demonstrate a superior capacity to resolve an outstanding scientific issue compared to current analytical and functional methodologies, the petition asserts that their obligatory inclusion is unnecessary solely due to their historical presence in the development process.
The principle is not that clinical trials should be eliminated, as Niazi stated. Rather, the fundamental principle is that each experiment must serve a genuine scientific purpose. If comprehensive and highly sensitive analytical, functional, and clinical-pharmacological evidence has already sufficiently addressed the pertinent question, then conducting large efficacy trials solely out of conventional practice leads to the unnecessary utilization of patient participants, significant time expenditure, and considerable resources, without necessarily improving the robustness of regulatory decisions.
Extending the Revolution Already Underway in Biosimilars
The petition builds on major changes already occurring in FDA’s regulation of biosimilars.
The Food and Drug Administration (FDA) has increasingly emphasized comparative analytical and functional characterization as the foundation for biosimilar development. Additionally, it has moved toward eliminating routine comparative clinical efficacy studies when such studies do not yield meaningful additional insights. Recent FDA policies have also aimed to streamline clinical pharmacology and comparator requirements, provided such simplifications are scientifically justified.
Niazi’s petition urges the FDA to promote the fundamental scientific principle by stipulating that the quantity and nature of evidence should be contingent upon the residual uncertainty associated with each product, rather than being exclusively dictated by a historical regulatory classification.
This principle is well-established in the context of conventional chemical drugs. Generic medicines typically do not duplicate the comprehensive clinical efficacy testing conducted by the original sponsor. Instead, they demonstrate pharmaceutical equivalence and bioequivalence through a significantly abbreviated development process.
For therapeutic-protein biosimilars, increasingly sophisticated analytical and functional comparisons can similarly eliminate the need to repeat portions of the originator’s clinical development.
The petition asks why that reasoning should stop automatically at therapeutic proteins.
From Generics and Biosimilars to a Product-Level Framework
The proposed framework intends to assess each candidate through a standardized sequence of inquiries involving:
Identity, organization and structure, impurities, biological or pharmacological function, exposure and persistence, and any new hazards introduced by the successor product or its manufacturing process.
The Food and Drug Administration (FDA) would initially assess whether the current legislation authorizes the proposed reference-based pathway. The scientific comparison would occur only after meeting this legal prerequisite.
This distinction holds considerable significance. The petition does not request the FDA to reinterpret the law outside its statutory limits. Should the FDA determine that a scientifically supportable follow-on product cannot be approved due to the absence of an appropriate legislative pathway, the petition requests that the agency explicitly identify these statutory barriers and advise Congress on targeted legislative amendments.
The petition additionally explicitly safeguards patent rights, statutory exclusivities, and established patent-resolution procedures. Its objective is not to diminish the duration of legal protection for innovation. Instead, it aims to clarify the subsequent developments following the point at which the law permits competition.
“Patent and exclusivity protections should appropriately reward innovation in accordance with Congress’s original intent,” Niazi stated. “However, once these protections cease to hinder competition, it is unnecessary to impose an additional scientific obstacle by mandating the repetition of experiments that no longer yield beneficial insights. The relevant question should be: What uncertainties remain, and what is the most accurate scientific approach available to resolve them?”
Potential Global Consequences
Although the Citizen Petition asks the U.S. Food and Drug Administration to act under American law, its implications may extend far beyond the United States.
The regulatory standards established by the Food and Drug Administration (FDA) markedly shape drug development strategies, investment choices, and regulatory expectations on a global scale. Should the United States adopt a scientifically rigorous approach to the development of follow-on versions of complex biological and advanced therapies—without automatically replicating the original manufacturer’s comprehensive clinical development program—manufacturers in regions with lower costs may discover a more feasible pathway to access markets that are presently economically inaccessible.
The greatest potential impact may originate from pharmaceuticals whose development costs and technical intricacies have enabled them to continue functioning as effectively sole sources, even after the expiration of conventional intellectual property rights that typically justify exclusivity.
Niazi believes this matters most for lower- and middle-income countries.
For approximately 80% of the global population, many of the latest biological and advanced pharmaceuticals are not realistically affordable, Niazi states. “Scientific innovation has furnished us with remarkable therapies, but an invention that remains economically inaccessible to the majority of humanity has not fulfilled its public health mission. It is essential to safeguard innovation while it is protected by legal frameworks and subsequently employ equally sophisticated science to promote responsible competition.”
Reducing unwarranted development expenses does not inherently determine a medication’s final price, nor does the petition assert this. Factors such as manufacturing complexity, supply chain logistics, regulatory obligations, market capacity, and commercial policies will continue to influence pricing. However, significantly diminishing redundant development efforts could potentially mitigate one of the principal barriers preventing new manufacturers from entering the market.
Greater competition may also enhance global supply resilience by diminishing reliance on a sole manufacturer for medically significant products.
Not a Lower Standard, but a More Discriminating One
The petition repeatedly distinguishes abbreviated development from reduced standards.
A subsequent manufacturer assumes full responsibility for its manufacturing process and for hazards not identified in the reference product. A novel impurity, a modified delivery system, a different cellular source, a changed vector, new genomic risks, or other successor-specific concerns cannot be dismissed solely on the basis that other product attributes appear similar.
Similarly, some products may fail to comply with the proposed framework entirely. This could be attributed to an inadequate understanding of the product, a lack of commercially available reference lots, analytical methods that do not reliably predict clinical performance, or legal restrictions that hinder the necessary reliance.
According to Niazi’s proposal, these outcomes would necessitate supplementary targeted studies or the cessation of the abbreviated program.
“A credible framework must be capable of affirming, negating, or postponing decisions,” Niazi stated. “This is not an assertion that all elements are subject to replication. Rather, it underscores that every product eligible on scientific and legal grounds warrants evaluation based on verifiable evidence, rather than being dismissed solely due to its product category name.”
A Possible New Global Model for Medicines After Exclusivity
If adopted, the framework could potentially delineate three principal stages in the lifecycle of an innovative medicinal product: complete independent development of the original product; protected commercial exclusivity for the innovator during the duration defined by patent and regulatory statutes; and, upon the cessation of such protections allowing competition, the scientifically expedited development of qualified follow-on products based on the approved reference.
Such a model could expand the fundamental concept that underpins the contemporary generic-drug industry and, consequently, the biosimilar industry, into a more comprehensive regulatory philosophy pertinent to therapeutics in the twenty-first century.
Instead of requiring each new manufacturer to independently verify information already recognized by the FDA regarding an established medicine, the regulatory authority would define explicitly what evidence must be provided to justify reliance on that existing knowledge.
For Niazi, the issue ultimately extends beyond regulatory efficiency.
The forthcoming advancement in the medical domain will not solely originate from the discovery of novel pharmaceuticals. It will also stem from developing scientifically rigorous methods to ensure that the pharmaceuticals already identified are accessible to those in need. A treatment that exceeds the financial capabilities of a nation or a family effectively equates to having no treatment at all for the affected patients.
The direct link to the petition, Citizen Petition: Request to Establish a Unified Reference-Anchored Equivalence Framework for Follow-On Human Drug and Biological Products, is accessible on Regulations.gov at https://www.regulations.gov/docket/FDA-2026-P-9683. The Citizen Petition and its supporting scientific analyses have been deposited in the Zenodo open-access repository.
Niazi, S. (2026). Request to Establish a Unified Reference-Anchored Equivalence Framework for Follow-On Human Drug and Biological Products. Zenodo. https://doi.org/10.5281/zenodo.22064742
About Professor Sarfaraz K. Niazi
Professor Sarfaraz K. Niazi is affiliated with the College of Pharmacy and Pharmaceutical Sciences at Washington State University and has worked extensively in pharmaceutical sciences, biotechnology, biosimilars, and regulatory policy. Niazi submitted the Citizen Petition in his individual capacity, and it should not be interpreted as an institutional filing or policy position of Washington State University.
Media Contact
Email: [email protected]
Telephone: +1-312-297-0000
View original content to download multimedia:https://www.prnewswire.com/news-releases/professor-sarfaraz-niazi-of-washington-state-university-files-fda-citizen-petition-seeking-new-pathway-to-make-high-cost-medicines-more-accessible-worldwide-302859625.html
SOURCE Professor Sarfaraz K. Niazi
