FDA Approves Abbreviated New Drug Applications for Everolimus Generic Drug

The FDA approved the first generic for everolimus (Afinitor) to treat patients with advanced hormone receptor–positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; progressive neuroendocrine tumors (NETs) of pancreatic origin; progressive, well-differentiated, non-functional NETs of gastrointestinal or lung origin that are unresectable; and renal angiomyolipoma and tuberous sclerosis complex.

Teva Pharmaceuticals and Par Pharmaceuticals submitted 2 abbreviated new drug applications (ANDAs) for the everolimus generic, which now that it is approved, could provide a safe, effective, lower cost alternative to the brand-name drug it references.

"We are pleased to bring the first generic Afinitor to market and provide patients with a lower-cost option," Domenic Ciarico, executive vice president and chief commercial officer of Sterile & Generics at Endo International plc, which operates Par, stated in a press release.

A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use, according to the FDA.

Of note, the application is considered abbreviated, compared with brand name drug approvals, because they are not always required to include preclinical or in human data to establish safety and effectiveness. Instead, the generic drug must show that it performs in the same manner as the branded drug.

To be approved by FDA, the generic version of a drug must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the original agent. 

In Teva's application, the generic tablets are approved at 2.5 mg, 5 mg, 7.5 mg, and 10 mg doses; Par Pharmaceutical's application is for 2.5 mg, 5 mg, 7.5 mg doses of the tablet.

Reference:

US Food and Drug Administration. First generic drug approvals. fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals. Accessed December 10, 2019.

Food and Drug Administration. Abbreviated New Drug Application (ANDA). https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda. Accessed December 10, 2019.