In September, Indian drug manufacturer Alembic received a tentative nod from the US Food and Drug Administration (FDA) to manufacture generic alogliptin as well as the alogliptin/metformin fixed-drug combination. As the first generic DPP-4 inhibitor class of medications enters the US market, it will be interesting to see how the prescriptions of other DPP-4 inhibitors that are still on patent, as well as other classes of diabetes medications, are affected.
Akshay B. Jain, MD
In 1984, Congress passed the Hatch-Waxman Act, which made it easier for the pharmaceutical industry to produce and market generic medications in the United States.[1] As of 2012, 84% of all US prescriptions were dispensed as generics.[1] Today, pharmacists in many states are required to dispense the generic version of a drug unless a doctor specifies otherwise.
The FDA approval of a generic drug requires demonstrability of bioequivalence or similar quality and performance as the original innovator drug. Although manufacturers aren't required to prove therapeutic equivalence in clinical trials, it is presumed that one would see similar efficacy, as the chemical composition is similar.
Mixed Perceptions About Generics
Despite the intense regulations and criteria laid down by the FDA for the quality of generic medications, perceptions of generic drugs by the public seem to be mixed.
