FDAnews Drug Daily Bulletin

Pharma Blog Watch

Jan. 14, 2013
Are Generics Really Equal to Brand Drugs? (World of DTC Marketing Blog)
The FDA’s definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20 percent below or 25 percent above that of the brand name, blogger Rich Meyer writes. Is the brand worth an 85 percent price premium? “Probably not,” Meyer writes. “But drug companies would be smart to lower prices of branded drugs significantly when their product comes off patent.”