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.
Absent legislative intervention, it appears that Mylan NV will have only a few days to secure US Food and Drug Administration approval of its follow-on to Sanofi’s Lantus (insulin glargine) once a 30-month legal stay expires.
Mylan’s insulin glargine application, which is partnered with Biocon Ltd