FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA ‘Confident’ that Interchangeable Insulin Will Be Available After March 2020

Dec. 21, 2018
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Approved NDAs for certain biological products will be deemed to be biologics licenses under new FDA policies beginning March 2020, allowing the products to compete under the biosimilars pathway and potentially lower drug costs.

Commissioner Scott Gottlieb announced the agency’s new policy Tuesday alongside a proposed rule and guidance that describe the planned transition, calling it a “watershed moment for insulin products.”

The agency’s proposal would lead to a small category of biological products currently regulated as drugs — such as insulin and human growth hormone — to be regulated as biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) and would “enable, for the first time, products that are biosimilar to, or interchangeable with, these products to come to market,” Gottlieb said.

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