MEXICO HOPES FOR BIOEQUIVALENT GENERICS
NAFAM, Mexico's association of drug manufacturers, claims that the country's bioequivalence and bioavailability laws -- which take effect this year -- are comparable with those in Europe or the US. However, observers increasingly question this view, or that any progress will be made in raising the sector's market share above the current 2.5% in the near term.
In fact, Mexico offers three levels of bioequivalence testing, and assessments for safety and therapeutic equivalence are seen by some as ambiguous. With certification tests costing up to US$120,000 per product, many generic drug producers have little incentive to invest. Nevertheless, government officials expect all drugs on the Mexican market to be certified by 2009.