6:30 AM
Dec 11, 2018
 |  BC Extra  |  Politics & Policy

FDA biosimilars policies will bring interchangeable insulin to market

New FDA policies will lead to approvals of interchangeable insulin products that can be automatically substituted for branded insulin, FDA Commissioner Scott Gottlieb said Tuesday.

Gottlieb made the prediction in a statement about new guidance documents that outline how FDA will implement a law requiring that it stop regulating certain biologics, such as insulin and human growth hormone, as drugs. Under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), biologics that have been approved under NDAs will be deemed on March 23, 2020, to be approved under BLAs.

The quirk in U.S. law that has regulated insulin under NDAs has limited competition because it has been difficult to...

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