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BLAs More Appealing As 'Transition' NDAs, ANDAs Set To Lose Exclusivity

 
• By Sue Sutter

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.

Licensure under the BLA pathway, even though it may have more testing requirements, appears to be a more attractive regulatory strategy than the NDA route in the near-term under FDA's interpretation of the Biologics Price Competition and Innovation Act's "transition provisions" for certain protein products.

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