Department of Clinical Pharmacology, Specialty Care Business Unit, Pfizer Inc., New London, CT, USA.
Mol Pharm. 2010 Oct 4;7(5):1539-44. doi: 10.1021/mp1001747. Epub 2010 Sep 7.
The Biopharmaceutics Classification System (BCS) is employed to waive in vivo bioequivalence testing (i.e. provide "biowaivers") for new and generic drugs that are BCS class I. Granting biowaivers under systems such as the BCS eliminates unnecessary drug exposures to healthy subjects and provides economic relief, while maintaining the high public health standard for therapeutic equivalence. International scientific consensus suggests class III drugs are also eligible for biowaivers. The objective of this study was to estimate the economic impact of class I BCS-based biowaivers, along with the economic impact of a potential expansion to BCS class III. Methods consider the distribution of drugs across the four BCS classes, numbers of in vivo bioequivalence studies performed from a five year period, and effects of highly variable drugs (HVDs). Results indicate that 26% of all drugs are class I non-HVDs, 7% are class I HVDs, 27% are class III non-HVDs, and 3% are class III HVDs. An estimated 66 to 76 million dollars can be saved each year in clinical study costs if all class I compounds were granted biowaivers. Between 21 and 24 million dollars of this savings is from HVDs. If BCS class III compounds were also granted waivers, an additional direct savings of 62 to 71 million dollars would be realized, with 9 to 10 million dollars coming from HVDs.
生物药剂学分类系统（BCS）用于免除新的和仿制药的体内生物等效性测试（即提供“生物豁免”），这些药物属于 BCS 分类 I。在 BCS 等系统下给予生物豁免，可以避免健康受试者不必要的药物暴露，并提供经济缓解，同时保持治疗等效性的高标准。国际科学共识表明，III 类药物也有资格获得生物豁免。本研究旨在估计基于 I 类 BCS 的生物豁免的经济影响，以及对可能扩展到 BCS 类 III 的经济影响。方法考虑了药物在四个 BCS 类别中的分布、五年期间进行的体内生物等效性研究的数量以及高度可变药物（HVD）的影响。结果表明，所有药物中有 26%属于非 HVD 的 I 类药物，7%属于 I 类 HVD，27%属于 III 类非 HVD，3%属于 III 类 HVD。如果所有 I 类化合物都获得生物豁免，每年可以节省 6600 万至 7600 万美元的临床研究费用。其中 2100 万至 2400 万美元的节省来自 HVD。如果也给予 BCS 类 III 化合物豁免，还将实现额外的 6200 万至 7100 万美元的直接节省，其中 900 万至 1000 万美元来自 HVD。
