Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Mol Pharm. 2017 Dec 4;14(12):4334-4338. doi: 10.1021/acs.molpharmaceut.7b00687. Epub 2017 Nov 7.
The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientists in regulatory agencies, academia, and industry toward its implementation and further expansion. This article describes how the review implementation of this guidance was undertaken at the FDA and results of these efforts over last dozen years or so across the new, and the generic, drug domains are provided. Results show that greater than 160 applications were approved, or tentatively approved, based on the BCS approach across multiple therapeutic areas; an additional significant finding was that at least 50% of these approvals were in the central nervous system (CNS) area. These findings indicate a robust utilization of the BCS approach toward reducing unnecessary in vivo BE studies and speeding up availability of high quality pharmaceutical products. The article concludes with a look at the adoption of this framework by regulatory and health policy organizations across the globe, and FDA's current thinking on areas of improvement of this guidance.
美国食品药品监督管理局（FDA）于 2000 年 8 月发布了关于应用生物药剂学分类系统（BCS）豁免体内生物等效性（BE）研究的指南。自那时以来，该指南在监管机构、学术界和业界的生物制药科学家之间引起了全球关注，他们对其实施和进一步扩展表现出了浓厚的兴趣。本文描述了 FDA 如何实施这一指南的审查，以及在过去十几年中在新药和仿制药领域取得的成果。结果表明，基于 BCS 方法，在多个治疗领域批准或暂定批准了超过 160 份申请；另一个重要发现是，这些批准中有至少 50%是在中枢神经系统（CNS）领域。这些发现表明，BCS 方法得到了广泛应用，以减少不必要的体内 BE 研究，并加快高质量药物产品的供应。本文最后探讨了全球监管和卫生政策组织对这一框架的采用情况，以及 FDA 目前对这一指南改进领域的思考。
