Teva filed a Citizen Petition with the FDA, in which it argued that synthesizing generic Copaxone would be "extremely difficult, if not impossible". In addition, because the drug is rapidly absorbed, bioequivalence studies would be inadequate, and full-fledged clinical studies using clinical outcomes would be required.
Leader Capital Markets analyst Yoav Burgan said that the decision was a very minor setback for Teva. "The FDA did not throw Teva down the stairs. It merely said that it was not prepared to address the case at this time because that would be premature. In its petition, Teva argued that approval of a generic version of Copaxone would require clinical trials because of the complexity of the molecule. The FDA said that it was premature to discuss the matter, so long as there is no decision about a potential approval of a generic version of Copaxone," he said.
Users browsing this forum: No registered users