Critical analysis of the licensing regulation for biosimilar products in Latin American countries in relation to the guidelines of the World Health Organization

Abstract

OBJECTIVES: To perform a critical analysis of the licensing regulation for Similar Biotherapeutical Products (SBP's) of Argentina, Brazil, Colombia and Mexico, having the World Health Organization (WHO) guidelines as the gold standard in relation to extrapolation of indication, clinical and non-clinical comparative studies and pharmacovigilance. Interchangeability, not included in the WHO guidelines, in accordance with the American National Regulatory Authority (NRA). METHODS: Descriptive study on licensing regulation for SBP’s in four countries in the Americas: Argentina, Brazil, Colombia and Mexico compared to the WHO guidelines for evaluation of PBS's. RESULTS: Brazil, Argentina and Mexico meet the WHO recommendations for extrapolation of data and pharmacovigilance. Argentina and Mexico comply comparative studies partially. Mexico is the only country that provides interchangeability of Reference Biological Products (PBR´s) by SBP´s. Colombia has no law referring to extrapolate data, comparative studies and interchangeability and partially meets the WHO guidelines to pharmacovigilance. CONCLUSION: The laws of Argentina and Brazil are the ones that meet most of the WHO recommendations. NRAs have crucial role in monitoring the development and production of these products. A continuous assessment of standards for PBS's licensing is needed for safety assurance of patients because each country´s needs are constantly changing.