The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers | FDA

The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers | FDA

Today, the Food and Drug Administration (FDA) has issued a final guidance for industry, “The ‘Deemed to be a License’ Provision of the BPCI Act:  Questions and Answers” that provides answers to common questions about FDA’s implementation of the “transition” provision of the 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 also has recently issued a final rule on the Definition of the Term ‘Biological Product’ and has published frequently asked questions (FAQ) documents for patients and health care professionals 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, healthcare providers, and patients. For more information on the transition, visit the “Deemed to be a License” Provision of the BPCI Act webpage.