On the day that almost 100 products switched from being regulated as drugs to biologics in the US – opening the door for the first time to applications for biosimilar and interchangeable versions – Sanofi’s Lantus (insulin glargine) stands alone as the only insulin product still listed in the “Orange Book.”
US Marks Biologics Transition Day
FDA Sees 96 Drugs Make The Move To Biologics Regulation
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.
