1. Generics Bulletin

Should US Insulins Be Treated As Biologics?

Draft Bill Favors ANDA Route For Insulins

 
• By Dave Wallace

Against a backdrop of continued outcry over insulin costs in the US and the looming FDA-imposed transition of insulins to biologic status in early 2020, legislators and manufacturers alike are still lobbying for alternative approaches to the essential diabetes treatment.

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The proposed ‘MAGIC’ Act would see generic insulin applications regulated as ANDAs • Source: Shutterstock

On 23 March 2020, insulins are due to switch to being regulated by the US Food and Drug Administration as biologics under the Biologics Price Competition and Innovation Act. This means that 505(b)(2) applications relying on originator insulins that are pending or only tentatively approved after 11:59pm on Friday 20 March will receive a complete response letter, and sponsors will have to resubmit the products as biologic license applications.

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