Copaxone glatiramer acetate regulatory update

Teva submitted a fourth Citizen's Petition to FDA that seeks to block approval of generic versions of the company's multiple sclerosis (MS) drug Copaxone glatiramer acetate. The petition, submitted June 4, requests the agency refuse to approve ANDAs for a generic version of Copaxone unless sponsors conduct clinical studies using safety and efficacy endpoints to establish the bioequivalence of the generic version to Copaxone. Teva also requested FDA require clinical and non-clinical studies to show that the immunogenicity of the generic version is equivalent to that of Copaxone.

Last year, the agency rejected a third Citizen's Petition from Teva in which the agency said it would be "premature and inappropriate" to decide on the approvability of any glatiramer acetate injection ANDA before the agency has reviewed specific data in an application or provided an applicant with "appropriate procedural protections" (see BioCentury, Dec. 20, 2010 & June 13, 2011). ...