House Appropriators Tip-Toe Into Biologics Transition Controversy
US FDA instructed to use the "Program" when assessing insulin applications with review goals before the 2020 transition date, but appropriations report does not explicitly urge elimination of the application "dead zone."
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Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.
Thirty-month stay resulting from Sanofi’s patent lawsuit expires on 18 March 2020, two days before Mylan’s application must receive final approval to avoid getting caught in the transition of insulins from drug to biologic regulation. Pre-approval inspection of Biocon’s manufacturing facility resulted in 12 ‘largely procedural’ observations, company says.
Discussion draft includes provision requiring completion of assessments of transitioning NDA applications filed by 23 September, even if review lasts beyond the official 2020 transition date.