Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays

Publication: Ther Innov Regul Sci
Division: Simulations Plus


Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

By Claudia Miranda-Pérez de Alejo, Alexis Aceituno Álvarez, Gustavo Mendes Lima Santos, Mirna Fernández Cervera, Helgi Jung-Cook, & Miguel Ángel Cabrera-Pérez