US Pharm:2011;35(1):60.
Teva Pharmaceutical Industries Ltd. announced that the company has filed a Citizen Petition (CP) with the FDA requesting that the agency refuse to approve any abbreviated new drug application (ANDA) for a purported generic version of Copaxone (glatiramer acetate injection). Teva bases its filing on the inability to establish acceptable “sameness” of the active ingredients in glatiramer acetate, the complexity of the mechanism of action of a glatiramoid, and the inapplicability of leveraging conventional pharmacokinetic and pharmacodynamic testing methods to demonstrate bioequivalence.
Teva urges that any purported follow-on version of Copaxone undergo preclinical testing as well as full-scale clinical trials with measured clinical end points in patients with multiple sclerosis to prove safety and efficacy. Teva also asked the FDA to convene a multidisciplinary advisory committee to consider the approval of follow-on glatiramer acetate products in the interest of public health.
