Affiliations: Faculty of Pharmaceutical Sciences, University of Sao
Paulo, Sao Paulo, Brazil | Faculty of Chemical and Phamaceutical Sciences,
University of Chile, Santiago, Chile | Brazilian Health Surveillance Agency, Brasilia, Brazil
Note: [] Corresponding author: Sílvia Storpirtis, Faculty of
Pharmaceutical Sciences, University of Sao Paulo, 580 Lineu Prestes Av.,
Butanta, Sao Paulo, Brazil. E-mail: sstor2011@gmail.com
Abstract: In the XIX and XX centuries, Latin American countries have
experienced several changes on politics and economics, facing problems related
to progress and growth, technological development, demographic transition, and
the environment. In the 2010s this region presents a high level of health
demands, which causes financial difficulties, especially in expenditures with
medicines. In this scenario have emerged policies to regulate and harmonize the
register of generic and similar products based on in vitro and in
vivo assays that support therapeutical equivalence and interchangeability, but
heterogeneity is still observed, especially in terms of the assessment criteria
and time from application until marketing authorization. Data obtained from the
pharmaceutical market predict that this segment could reach USD 1,200 billion
by 2016, mainly from market expansion in the leading emerging countries and
from generics. The aim of this article is to present and discuss relevant
aspects on bioequivalence, and biowaivers criteria, highlighting the different
approaches adopted by the regional regulatory authorities in Latin America.
Keywords: Generic drugs, similar products, pharmaceutical regulation, bioequivalence, biowaivers, Latin American countries
