Biologics Exclusivity: Key Questions Unlikely To Have Clear Answers From US FDA
FDA’s embrace of biosimilars as part of the drug pricing response means a flurry of guidances coming soon. But don’t expect much clarity on key issues for innovators, like the boundaries of 12-year exclusivity and whether it will apply to NDA products that transition to BLAs, says a former CDER attorney.
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Additionally, potential regulation to require clinical study sponsors to promptly report suspected data falsification seems to have found new life after being listed as inactive in July update of the Unified Agenda.
The US Food and Drug Administration has published new draft guidance describing how it plans to take certain protein products that have been approved through Food, Drug and Cosmetic Act (FDCA) processes like the new drug application (NDA) pathway and move them over to the biologics license application (BLA) process1.
While FDA has laid out the types of information it wants sponsors to provide, agency acknowledges it cannot easily write guidance stating the extent of structural changes to a molecule that would justify a new period of exclusivity.