Teva Loses Bid to Have MS Drug Reclassified as Biologic

Teva Pharmaceuticals USA Inc. failed to convince a Washington, D.C., federal court that its multiple sclerosis drug Copaxone was a “protein” the U.S. Food and Drug Administration should consider a biological product instead of a drug.

The U.S. District Court for the District of Columbia on Dec. 31 called Teva’s suit “yet another effort to stifle Copaxone competitors” after its “concerted resistance” to the approval of generic versions of Copaxone.

It’s important for Teva that Copaxone be considered a complex “biologic” rather than an easily re-created “drug” because then it can guarantee that prescriptions for its name brand are filled ...