BRANDED DRUGS, UNSAFE COPIES CHALLENGE BRAZILIAN GENERICS

Despite official data suggesting that generics now account for some 17% of Brazil's drug market -- with a value of US$1.5bn -- local reports claim that distribution is not even across the country, and there is still tough competition from non-bioequivalent copies.

Brazil's drug regulator Anvisa estimates that 70% of all drugs sold in Brazil are copies of an off-patent drug, but the agency only introduced bioequivalence and bioavailability requirements in 2003. In December, Anvisa removed 130 copy drugs from the market after data submissions revealed dangerously high levels of active ingredients. Unsurprisingly, some consumers have remained cautious on generics, staying with their traditional preference for branded drugs.

A further key problem is that generics in Brazil -- while often up to 40% cheaper than original drugs -- are still more expensive than non-bioequivalent copies. This is partly due to higher retail margins allowable on approved generics. Taking one example, a local copy of Pfizer's off-patent antifungal Diflucan (fluconazole) is available at roughly half the branded drug's price, while a bioequivalent generic marketed by Brazil's Medley offers a discount of just 26%.

Although Brazil's government has introduced generics-friendly measures such as tax breaks, the branded sector remains strong -- and occasionally supported by quasi-illegal prescribing incentives. In the meantime, Brazilian consumers are likely to remain insufficiently aware of savings offered by safe, bioequivalent generic alternatives.