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

Semglee, a follow-on version to Sanofi’s Lantus, finally wins approval more than two months after insulin products transitioned to regulation as biologics; the product is not a biosimilar but can serve as a reference biological for future biosimilar or interchangeable applications from other sponsors.