CHICAGO, Aug. 6, 2024 — Professor Sarfaraz K. Niazi of the University of Illinois has published a research paper in the journal Pharmaceuticsi and filed a Citizen Petition to advise the US FDA to remove its 2017 ban on the US Pharmacopeia (USP) from developing analytical specifications of biological drugs that can enable removal of side-by-side analytical assessment of biosimilars that will reduce the cost of biosimilar development and establish a global standard of quality.
Professor Niazi, a biosimilars pioneer with dozens of textbooks, hundreds of research papers, and a history of FDA-approved biosimilars, created a new class of “monograph” that will not be labeled as a monograph. Instead, it will be called Biological Product Specification (BPS), which the USP will develop using commercial lots of reference products, just as the developers do. It will also provide validated test methods, removing the need for side-by-side testing of biosimilar candidates with their reference product.
“Biosimilars have failed to fulfill their role as over the past 15 years, only 15 molecules have come up as biosimilars, while hundreds are available, and even then, the cost has not dropped as anticipated due to the high cost of hundreds of millions of dollars and years to develop biosimilars. The backbone of biosimilarity is the analytical comparison that requires creating testing methods, obtaining ten lots of reference products, and conducting extensive testing. This can be removed if the US Pharmacopeia accepts this task and provides release specifications and test methods. In this case, all a biosimilar development does is test a small number of lots for meeting this specification; I anticipate that the FDA will be responsive as it has always been to favor scientific arguments and enable the USP to provide this service,” said Professor Niazi in an interview with Forbes Magazine.
In supporting Professor Niazi’s proposition, the SVP of Global Biologicals at the USP, Dr. Fouad Atouf, said, “It is crucial to remove barriers to testing biosimilars through reference standards, analytical methods, or quality guidelines. USPii is prioritizing the development of state-of-the-art analytical tools to accelerate the advancement of biologics and biosimilars. This supports continuous innovation, reduces barriers to market access for quality medicines, and provides solutions available to stakeholders across the global supply chain. Because of our longstanding work with manufacturers and regulators to ensure the quality of medicines, USP is uniquely positioned and eager to partner with government agencies, including the FDA, to remove obstacles and build solutions to bring biosimilars to patients faster.”
Professor Niazi is now expecting the US FDA to take the lead and implement this pivotal change, dramatically changing the accessibility of biological drugs globally.
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i 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
ii (https://www.usp.org/biologics/biosimilars)
SOURCE Professor Sarfaraz K. Niazi
