Home » Dispute Over Exclusivity Emerges as Latest Biosimilars Battle
Dispute Over Exclusivity Emerges as Latest Biosimilars Battle
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
Washington Drug Letter
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