Regulatory Focus™ > News Articles > FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs

FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs

Posted 22 July 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released 37 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence.

Background

Bioequivalence refers to the "absence of a significant difference" between the bioavailability—specifically the extent and rate of absorption—of two (supposed) pharmaceutical drug equivalents over the course of a period of time, at the same dose and under the same conditions. "The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug," FDA explains on its website.

Drugs that are deemed to be bioequivalent are, for regulatory purposes, essentially the same.

But in practical terms, generic drug companies are often most concerned with two things:

how to prove that two drugs are bioequivalent
how to show bioequivalency in a way that will be acceptable to FDA

In order to facilitate that process, FDA regularly publishes what it calls "bioequivalence recommendations for specific products," which contains more than 1,000 recommendations.

These recommendations most often contain the recommended number of bioequivalence studies that must be conducted in order to obtain approval, as well as the general designs of the study, acceptable parameters of bioequivalency, and any other considerations sponsors must keep in mind.

New Standards

On 22 July 2014, FDA released 37 new BE standards, including ones for generic versions of Janssen's Invokana, Pfizer's Xalkori, Biogen Idec's Tecfidera, and AstraZeneca's Nexium 24HR.