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.
In a new draft guidance, FDA explains how it will implement the "deemed to be a license" provision in Section 7002(e) of the Biologics Price Competition and Innovation Act (BPCIA)