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

By Jessica Karins / November 29, 2023 at 6:10 PM
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. The office says its interpretation benefits public health by...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.