Teva Pharmaceutical Industries Ltd. today announced that the FDA has responded to their Citizen Petition (CP) regarding COPAXONE(R) (glatiramer acetate injection). The FDA declined to review the CP “without comment on the approvability of any Abbreviated New Drug Application (ANDA) or New Drug Application (NDA) for a glatiramer acetate injection drug product because it would be premature and inappropriate to do so at this time.” The Agency’s guidelines required a response to this Citizen Petition by March 26, 2009. The FDA has not yet addressed or taken action on the requests that Teva presented in its Citizen Petition. According to the Agency, it is not possible to render a final decision on specific requirements for approval of any ANDA or NDA for glatiramer acetate injection “when a decision on the approvability of any such application has not been made.” A generic version of COPAXONE(R) cannot be introduced before it receives final approval of its ANDA from the Agency. COPAXONE(R) is a glatiramoid, a complex mixture of the acetate salts of synthetic polypeptides, non-uniform with respect to molecular weight and sequence. Due to the variability of the composition of the polymers, Teva believes that fully characterizing this mixture would be extremely difficult, if not impossible. Moreover, once subcutaneously injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult. Therefore, Teva believes that evidence supporting the effectiveness of a generic copy of glatiramer acetate cannot be derived from bioequivalence studies but rather must be derived from full-fledged clinical studies using clinical outcomes.
