FDA releases final rule and FAQs related to the upcoming biological product transition

Today, the Food and Drug Administration (FDA) is issuing a final rule and frequently asked questions related to the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act requires that a marketing application for a “biological product” (that previously could have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)) must be submitted as a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act).  This requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020.  On March 23, 2020, the BPCI Act requires that an approved marketing application for a “biological product” under section 505 of the FD&C Act shall be deemed to be a license for the biological product (i.e., an approved BLA) under section 351 of the PHS Act.  The transition of biological products currently regulated under the FD&C Act to the PHS Act will allow for the submission and approval of marketing applications for new products that are biosimilar to, or interchangeable with, the transition biological products.

In anticipation of the transition, the FDA has issued a final rule on the Definition of the Term ‘Biological Product’ and has also published frequently asked questions for patients and health care professionals regarding the transition of biological products. To help ensure a smooth transition, the FDA is providing these resources for manufacturers, and relevant information for patients and health care providers about the transition.

The final rule on Definition of the Term ‘Biological Product’ finalizes the December 2018 proposed rule and amends the FDA’s regulation that defines “biological product” to reflect changes made by the BPCI Act and the Further Consolidated Appropriations Act, 2020 and to provide the FDA’s interpretation of the statutory term “protein.” The final rule is intended to clarify the statutory framework under which products are regulated.  Under the final rule, the statutory term “protein” means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. 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.”  Therefore, the FDA is not finalizing the interpretation of the term “chemically synthesized polypeptide” proposed in December 2018.

Lastly, the FDA is also issuing two frequently asked questions (FAQ) documents for patients and health care providers to provide relevant information on the transition of biological products.

The FDA is working to ensure that there is a seamless transition between from one regulatory pathway to another and that there are minimal impacts on manufacturers and patients. For more information on the transition visit the “Deemed to be a License” Provision of the BPCI Act webpage.