FDA warning letter: Pfizer’s generic of top-selling MS drug Copaxone likely to be delayed

fda logo FDA warning letter: Pfizers generic of top selling MS drug Copaxone likely to be delayedFood and Drug Administration (FDA) clearance of Pfizer Inc.’s generic version of the top-selling multiple sclerosis (MS) drug Copaxone is expected the first quarter of 2017, but an agency warning letter disclosed last week regarding a May 2016 inspection could delay that approval.

Copaxone is manufactured by Teva Pharmaceutical Industries Ltd., and is one of the world’s best-selling drugs, generating sales of $3.5 billion last year in the U.S. alone. Pfizer’s generic, called Glatopa, is manufactured partnership with Sandoz Inc. and Momenta Pharmaceuticals Inc. Glatopa has been available in a 20-milligram version since 2015, but the 40-milligram version makes up about 84 percent of U.S. sales of Copaxone.

Teva has tried unsuccessfully to keep the generic 40-milligram version off the market through patent litigation. News of the generic’s delay is an obvious coup for Teva.

Pfizer said it is working hard to “identify assessments and potential corrective actions to ensure the FDA’s observations are addressed.” It hasn’t said when the issue may be resolved.

Meanwhile, Teva faces competition from other drug companies, such as Mylan Inc., who have applied to make generic versions of Copaxone as well and are currently awaiting FDA clearance.

A yearly dose of the brand name Copaxone costs about $85,000, compared to $67,000 for Glatopa. The 40-milligram dosage is preferred by most doctors and patients because it can be injected less often than the 20-milliliter version.

The warning letter is expected to be posted on the FDA website next week.

Source: Law360