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

 
• By Michael Cipriano

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.'

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US FDA Commissioner Scott Gottlieb has officially closed the door on 12-year exclusivity for currently approved insulins and other protein products that will be "deemed to be licensed" under the Public Health Service (PHS) Act in March 2020, a move that is likely to open the door to litigation against the agency from innovators.

"We will not confer exclusivity that sponsors never expected nor were intended to receive," Gottlieb said Dec. 11 at the...

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