US FDA's Gottlieb Shuts The Door On Exclusivity For 'Transition' Biologics

With an eye toward interchangeable insulins, FDA commissioner says existing protein products that will be 'deemed to be licensed' as biologics in March 2020 will not gain any additional exclusivity; coupled with the loss of existing unexpired exclusivity, the decision may spur innovator lawsuits against the agency for an unconstitutional 'taking.'