Biologics Transition Plan From US FDA Will Consider Therapeutic Equivalence Ratings
While industry awaits formal guidance ahead of March 2020 transition deadline for certain protein products, FDA's Christl says plan will take into account therapeutic equivalence ratings when deciding whether products are 'deemed' licensed as full biologic applications or biosimilars.
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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.
Certain protein products approved under FD&C Act before March 23, 2020 would lose their remaining non- orphan exclusivity, and would not qualify for 12-year biologic exclusivity.