Mylan/Biocon’s Insulin Glargine Has Narrow Window For Approval In US
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.
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Against a backdrop of continued outcry over insulin costs in the US and the looming FDA-imposed transition of insulins to biologic status in early 2020, legislators and manufacturers alike are still lobbying for alternative approaches to the essential diabetes treatment.
Biocon has run into fresh trouble with the US Food and Drug Administration after receiving a complete response letter on its application for insulin glargine, a proposed rival to Sanofi’s top-selling Lantus biologic.
Many of the products most commonly sighted as in need of a price break are not eligible under the legal framework described.