FDA Memo: Interchangeable Drug Makers Can’t Extend Exclusivity Periods

FDA’s biosimilars office issued an opinion in an internal memorandum that exclusivity periods for the first interchangeable drug in a class cannot be extended by the manufacturer’s decision not to bring the drug to market, including in cases where the interchangeable manufacturer has previously been sued by the maker of the reference product, overturning a Purple Book entry and providing insight into how FDA will address the issue in forthcoming guidance.