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US Marks Biologics Transition Day

FDA Sees 96 Drugs Make The Move To Biologics Regulation

 
• By Sue Sutter

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.

Open wooden door to the new world with green environment. Climate change concept.
The FDA’s door is now open to applications for biosimilar and interchangeable insulins • Source: Shutterstock

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.”

23 March was transition day for insulins, human growth hormone and other protein products originally approved as new drug applications

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More from Policy & Regulation

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• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

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US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
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