Niazi Sarfaraz K
College of Pharmacy, University of Illinois, Chicago, IL 60015, USA.
Pharmaceutics. 2024 Jul 30;16(8):1013. doi: 10.3390/pharmaceutics16081013.
Pharmacopeia monographs are not intended to establish biosimilarity. However, the US Food and Drug Administration (FDA) has stopped the US Pharmacopeia (USP) from creating monographs for biological drugs due to the need for side-by-side comparisons with the reference products. The USP can create Biological Product Specifications (BPS), not to be labeled as monographs, based on the analytical testing of reference products and validated test methods that will remove the need for side-by-side analytical testing of biosimilars with reference products. Scientific arguments confirm that this plan is logical and capable of creating global quality standards for biosimilars to allow their interchangeability with other biosimilars. While the regulatory agencies have waived many high-cost biosimilar tests, analytical assessment is the most sensitive test; reducing its cost will further enhance the entry of biosimilars with no clinically meaningful difference.
药典专论并非旨在确立生物相似性。然而，由于需要与参比产品进行并行比较，美国食品药品监督管理局（FDA）已阻止美国药典（USP）为生物药品制定专论。基于参比产品的分析测试和经过验证的测试方法，USP可以制定生物制品规范（BPS），但不得标注为专论，这将消除对生物类似药与参比产品进行并行分析测试的需求。科学论证证实，该计划是合乎逻辑的，并且能够为生物类似药制定全球质量标准，以使其能够与其他生物类似药互换使用。虽然监管机构已经免除了许多高成本的生物类似药测试，但分析评估是最敏感的测试；降低其成本将进一步促进无临床意义差异的生物类似药的进入。
