As the FDA works behind the scenes to determine how it will regulate the approval pathway for biosimilars, a debate between brand- and generic-drug makers is brewing over how the exclusivity period included in the pathway should work. The dispute between the industries first became known last month when a group of House lawmakers sent a letter to FDA Commissioner Margaret Hamburg expressing concern that the agency was misinterpreting the 12-year exclusivity period. The dispute over exclusivity adds to the stark differences between the industries that have emerged over what standards the FDA should use to approve a biosimilar in the first place.
Washington Drug Letter