Unit of Modeling and Experimental Biopharmaceutics, Centre of Chemical Bioactive, Central University of Las Villas, Villa Clara, 54830, Santa Clara, Cuba.
ANAMED Department, Institute of Public Health, Chile and Faculty of Pharmacy, University of Valparaiso, Valparaiso, Chile.
Ther Innov Regul Sci. 2021 Jan;55(1):65-81. doi: 10.1007/s43441-020-00191-7. Epub 2020 Jun 29.
The replacement of traditional in vivo bioequivalence studies by in vitro dissolution assays, based on the biopharmaceutical classification system (BCS), has emerged as an important tool for demonstrating the interchangeability of multisource products. This paper summarizes the current implementation of the BCS-based biowaiver for the development of multisource products in Latin America, and identifies several challenges and opportunities for greater convergence and application of BCS regulatory requirements.
Differences and similarities between the current BCS-based biowaivers' guidelines proposed by two relevant regulatory agencies for the Latin American region (FDA and WHO) and the new ICH harmonization guideline were identified and compared. An update of the BCS-based biowaiver guideline for Latin American countries was also considered, based on the respective regulatory information on bioequivalence studies, which is publicly available.
About 50% of the Latin American countries analyzed have no information on the implementation of any bioequivalence standards, while in the countries where bioequivalence studies are considered, the acceptance and application of BCS-based biowaiver requirements is quite heterogeneous. This situation contrasts with the international trend of global harmonization for BCS-based biowaiver guidance, suggesting the need in Latin America to identify opportunities and overcome challenges to improve the development of BCS-based biowaivers to avoid costly and time-consuming in vivo bioequivalence studies.
The study shows that the region is in a position to improve access to safe and effective medicines at a reasonable cost by applying BCS-based biowaiver guidance.
基于生物药剂分类系统（BCS）的体外溶出度测定替代传统的体内生物等效性研究，已成为证明多来源产品可互换性的重要工具。本文总结了拉丁美洲目前基于 BCS 的生物豁免在多来源产品开发中的实施情况，并确定了实现 BCS 监管要求更大趋同和应用的若干挑战和机遇。
确定并比较了两个相关监管机构（FDA 和 WHO）为拉丁美洲地区提出的现行基于 BCS 的生物豁免指南与新的 ICH 协调指南之间的差异和相似之处。还考虑了根据各自可公开获得的关于生物等效性研究的监管信息，更新拉丁美洲国家基于 BCS 的生物豁免指南。
在所分析的约 50%的拉丁美洲国家中，没有关于实施任何生物等效性标准的信息，而在考虑进行生物等效性研究的国家中，基于 BCS 的生物豁免要求的接受和应用存在很大差异。这种情况与基于 BCS 的生物豁免指导的国际全球协调趋势形成对比，表明拉丁美洲需要确定机会并克服挑战，以改进基于 BCS 的生物豁免的开发，从而避免昂贵和耗时的体内生物等效性研究。
该研究表明，该地区有机会通过应用基于 BCS 的生物豁免指导，以合理的成本获得安全有效的药物。
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