During these challenging times when the world is focused on COVID-19 and the matters at hand, it’s understandable if you didn’t take much notice of March 23 as a significant date – one that’s been on the FDA’s radar for a while. March 23, 2020, was the date when certain New Drug Applications (NDAs) were deemed Biologic License Applications (BLAs). Below are key milestones in the timeline that illustrate how we got here:
- March 23, 2010 – FDA enacts Biologics Price Competition and Innovation Act of 2009 (BPCI Act)
Pursuant to this Act, any applications for biological products approved as NDAs would be “deemed to be” BLAs as of March 23, 2020. This mainly applied to those protein products that were not chemically synthesized polypeptides.
- December 2018 – FDA publishes guidance for Industry
The FDA guidance Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 provided sponsors with precise details regarding the statutes and specifics for certain types of applications.
- September 24, 2019 – FDA posts Preliminary List of Approved NDAs as of August 31, 2019, that will be converted to BLAs
- Now – FDA publishes comprehensive list of Approved NDAs that were considered to be BLAs on March 23, 2020
This list includes those NDAs approved as of December 31, 2019.
If a sponsor had a pending application for a protein product under section 505 of the FD&C Act prior to this date, they would have needed to be in discussions with the FDA about their plan to transition to be in conformity with the requirements under section 351 of the Public Health Service Act. If you are a sponsor who has an NDA that is being converted, the FDA should have sent a letter on March 23, 2020, advising you that your approved application no longer exists as an NDA, but rather is now considered a BLA and will be regulated accordingly.
The technicality around this action was triggered by the Biologics Price Competition and Innovation Act of 2009, which clarified the statutory authority under which certain protein products would be regulated by amending the definition of a “biological product” to include a “protein (except any chemically synthesized polypeptide).”
Why does all this matter? Most importantly, this deadline means that any follow-on products for these NDAs will need to win approval as a biosimilar. Sponsors will need to deploy the proper regulatory strategies and guidance that support the development of a biosimilar.
If you are a sponsor that has an NDA that has been converted to a BLA or you are seeking to develop a regulatory strategy for future development of a “biosimilar,” please reach out to our Regulatory experts.