Abstract
Latin America accounts for approximately 8 per cent of the global generic market. Generics participation in the Latin American countries has been growing — however, the concept of generics differs considerably from country to country. In such landscape, Brazil has been distinguished not only because of the rigorous sanitary legislation — requiring bioequivalence tests and Good Manufacturing Practices certification for generic registration and aligning local regulation with internationally recognised scientific standards for proof of efficacy and safety — but also because of the market performance the generics have shown since their implementation in 1999. Annual sales reached US$717m and 157m units in 2005 and displayed the highest growth rates among the different segments within the Brazilian pharmaceutical market. This paper reviews the Brazilian experience with generics, focusing on current regulatory and market issues and on the main challenges and opportunities expected for the near future in this region.