Updates to the Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020

Updates to the Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020

Today, the Food and Drug Administration (FDA) posted an updated Preliminary List of Approved New Drug Applications (NDAs) for Biological Products That Will Be Deemed to be Biologics License Applications (BLAs) on March 23, 2020. To enhance transparency and facilitate planning for the March 23, 2020, transition date, the FDA posted in December 2018 a preliminary list of approved applications for biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and that will be affected by this statutory transition provision. The FDA explained that the agency intended to periodically update this preliminary list before the March 23, 2020, transition date, and posted an earlier update on September 23, 2019. This updated preliminary list is current through December 31, 2019. Three of the four approved applications for biological products added to the preliminary list reflect a change to the statutory definition of “biological product” made by the Further Consolidated Appropriations Act, 2020, which was enacted on December 20, 2019. The Further Consolidated Appropriations Act, 2020, removed the parenthetical “(except any chemically synthesized polypeptide)” from the category of “protein” in the statutory definition of “biological product.”  

The public may comment on this list by submitting a comment to the public docket established for this list and the draft guidance on “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers” (Docket No. FDA-2015-D-4750). To ensure that the agency considers any additional comments on the list before the statutory transition date, submit either electronic or written comments no later than February 19, 2020. 

The FDA is working to ensure that there is a seamless transition between regulatory pathways and that there are minimal impacts on manufacturers and patients. For more information on the transition visit the FDA’s webpage for the "Deemed to be a License” Provision of the BPCI Act.