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A Guide To US FDA’s Drug-To-Biologic Transition Process

 
• By Sue Sutter

As agency's hearing approaches, a Pink Sheet graphic charts the path for pending and approved applications for insulin, human growth hormone, and certain other protein products when the BPCIA ‘transition provisions’ take effect in March 2020.

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At the stroke of midnight on 23 March 2020, insulin and certain other drugs will become biologics in the US. • Source: Shutterstock

The complex process by which dozens of protein products will shift from regulation as drugs to biologics in March 2020 may face renewed scrutiny at an upcoming US Food and Drug Administration hearing on biosimilar and interchangeable insulins.

Under the Biologics Price Competition and Innovation Act “transition provisions,” insulin, human growth hormone and certain other types of protein...

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