FDA Biologic Transition Plan Creates 'Dead Zone' For Applications, Sponsors Fear

Industry objects to proposal that certain protein product applications pending as of March 23, 2020, will have to be resubmitted as BLAs – and to the idea that transitioned products will lose non-orphan exclusivity.

FDA's interpretation of the Biologics Price Competition and Innovation Act's "transition provisions" for certain protein products would create a "dead zone" or "blackout" period for new applications that could last several years, industry stakeholders say.

In comments responding to an FDA draft guidance on the BPCIA's "deemed to be a license" provisions, representatives from innovator, generic and biosimilar industries say the agency should allow pending...

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