Not A Biosimilar: Mylan’s Insulin Glargine ‘Deemed’ A BLA With Long-Awaited US FDA Approval

More than two months after US regulation of insulin products changed from drugs to biologics, the Food and Drug Administration approved what is believed to the only insulin application pending at the time of the transition.

On 11 June, the agency approved Mylan NV and Biocon Ltd.’s Semglee (insulin glargine) in two dosage forms: a 10mL multiple-dose vial and a 3mL single-use prefilled pen. The regulatory nod came in the application’s third review cycle, as approval was delayed by two complete response letters resulting from manufacturing quality issues