The Last Days Of NDAs: Uncertainties Remain Ahead Of 23 March Move From Drugs To Biologics
Exactly how many NDAs ultimately will make the switch, the impact of pending applications on 'Orange Book' listings, and the ramifications for ‘authorized generics’ are areas of focus as the regulatory transition date looms.
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Biologics with their brand name dropped from the label could become the alternative to an ‘authorized biosimilar,’ which is not allowed under the law.
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.
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.