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Insulin Applications Intended For Biosimilar Pathway May Already Be At US FDA

 
• By Derrick Gingery

In congressional testimony, outgoing Commissioner Scott Gottlieb says FDA already has "a lot of applications in-house" and robust interest when asked about the 2020 transition of insulin from regulation as a drug to a biologic.

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Outgoing US FDA Commissioner Scott Gottlieb implied that applications for follow-on insulins already may be arriving at the agency as part of a flurry of activity in anticipation of the opening of the biosimilar pathway to the products.

Insulin is among the products currently regulated as a drug that on March 23, 2020 will be deemed a biologic, which will open the

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