Regulating the Copy Drug Market in Brazil: Testing Generics and Similar Medicines (1999–2015)

Abstract

The chapter, written by Marilena Correa, Maurice Cassier and Maria Andrea Loyola, shows the formation, expansion and regulation of the similar and generic medicines’ markets since the 1990s. In particular, it explores the diffusion of bio-equivalence tests for the copy of both similar and generic medicines. The bio-equivalence tests carried out in centres authorized by ANVISA measure the quality of copies to guarantee their interchangeability with first medicines. The growth of the bio-equivalence test market and the extension of the network of bio-equivalence centres approved by the Health Surveillance Agency is a keystone in the construction of the pharmaceutical innovation system. In 2000, the national bio-equivalence centres performed only 27 percent of all bio-equivalence tests, whereas in 2010 they performed 87 percent of them. The process of standardizing Brazilian copies has until now been oriented primarily towards the needs of the domestic and regional markets. Obtaining the WHO prequalification standard could represent a new frontier of this standardization, aimed at international donor markets such as those of the Global Fund. To date, no Brazilian firm has acquired WHO prequalification, in contrast to Indian firms which make substantial use of them to conquer global generics markets.