Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products
Abstract
:1. Introduction
- The FDA withdrew a pivotal guideline for the analytical comparison [12] of biosimilars with their reference products using statistical modeling once it was demonstrated that the modeling was deficient in a citizen petition [13]; instead of revising the guideline, the FDA issued a new guideline [14] that notably changed the terminology from “comparison” to “assessment” and removed the challenged tier 1 statistical modeling and made the analytical biosimilarity testing more rational.
- The FDA interpreted the clinical efficacy testing requirement of the BPCIA as pharmacodynamic attributes, where available, such as erythropoietin, filgrastim, etc. [18,19]. This position of the FDA was questioned since the “omics” concept introduced by the FDA was considered impractical and irrelevant [20].
- In 2023, the FDA encouraged developers to create testing methods based on generally accepted scientific knowledge [21]; one recent change [22] on this basis was made by the FDA, allowing interchangeable status to biosimilars without additional switching and alternating studies that were questioned [23], while a Senate bill is in place to remove the interchangeable status of biosimilars from the legislation [24].
- The 21st Century Cures Act [29] includes a specific mandate for reference product companies to make their samples available to biosimilar developers. This mandate is part of the “Fair Access for Safe and Timely (FAST) Generics Act” provision within the Cures Act, requiring branded (reference product) companies to provide enough of their product to biosimilar and generic drug developers. This ensures that developers can conduct necessary testing to demonstrate bioequivalence and meet regulatory requirements. This provision aims to prevent anti-competitive practices, where reference product companies might refuse to supply their products, thereby hindering the development of more affordable biosimilars and generics. However, the implementation of this Act has failed as the branded companies have adopted various means of keeping their samples restricted from biosimilar developers by their availability and cost, as the developers need to secure multiple branded lots manufactured at different times. This exercise has become a critical hurdle in testing biosimilars.
2. Pharmacopeial Monographs
3. The FDA Stops Monographs
4. Biological Product Specification (BPS)
5. BPS Attributes (BPSA)
6. Advantages
7. Conclusions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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Niazi, S.K. Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products. Pharmaceutics 2024, 16, 1013. https://doi.org/10.3390/pharmaceutics16081013
Niazi SK. Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products. Pharmaceutics. 2024; 16(8):1013. https://doi.org/10.3390/pharmaceutics16081013
Chicago/Turabian StyleNiazi, Sarfaraz K. 2024. "Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products" Pharmaceutics 16, no. 8: 1013. https://doi.org/10.3390/pharmaceutics16081013