The Biologics Price Competition and Innovation Act of 2009 (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 10-year transition period between the law’s enactment on March 23, 2010, and March 23, 2020, provides sponsors of biological products that are affected by the statutory transition with time to prepare for the transition, and allows biological products submitted under section 505 of the FD&C Act time to be approved before March 23, 2020.
FDA is working to ensure that there is a seamless transition between regulatory pathways and that there are minimal impacts on manufacturers and patients.
Although the majority of therapeutic biological products have been licensed under the PHS Act, some protein products (e.g., insulin and insulin analogs, human growth hormone, pancreatic enzymes, reproductive hormones) historically have been approved in new drug applications (NDAs) under the FD&C Act.
The BPCI Act clarified the statutory authority under which these protein products will be regulated by amending the statutory definition of a “biological product” in the PHS Act to include a “protein (except any chemically synthesized polypeptide),” and describing procedures for submission of a marketing application for these protein products. The Further Consolidated Appropriations Act, 2020, enacted on December 20, 2019, further amended the definition of a “biological product” in the PHS Act to remove the parenthetical “(except any chemically synthesized polypeptide)” from the statutory category of “protein,” meaning that such chemically synthesized products are now within the definition of “biological product” and subject to the statutory transition. This legislative change only affects chemically synthesized products that fall within the interpretation of “protein” (see updated Preliminary List below); this legislative change does not affect “peptides” (i.e., polymers composed of 40 or fewer amino acids).
- For proposed products, the BPCI Act describes the approval pathways that are available for submission of a marketing application for biological products subject to the transition. After March 23, 2020, all sponsors seeking approval of a biological product that previously could have been submitted under section 505 of the FD&C Act will need to submit a marketing application under section 351 of the PHS Act; either:
- a 351(a) BLA (i.e., a “stand-alone” BLA); or
- a 351(k) BLA for a proposed biosimilar product or a proposed interchangeable product.
- For approved products, the BPCI Act requires that an approved marketing application for a “biological product” under section 505 of the FD&C Act be deemed to be a license for the biological product (i.e., an approved BLA) under section 351 of the PHS Act on March 23, 2020, and regulated under the PHS Act. Once this transition occurs, sponsors can seek approval of products that are biosimilar to, or interchangeable with, these transitioned products.
For additional information on the statutory transition, please refer to the resources below.
- FDA Guidance for Industry, Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009
- FDA Guidance for Industry, The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers
- Definition of the Term “Biological Product”, Final Rule
- MAPP 5016.3 - Responsibility in OPQ for the Integrated Quality Assessment of Products Containing Drug Substances Composed of Amino Acid Polymers
- List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 (corrected)
- List of Withdrawn Applications for Biological Products That Were Removed From FDA’s Orange Book on March 23, 2020
- Other Information and Resources
- Information for Patients About Regulatory Changes for Certain Biological Product Medications
- Information for Health Care Providers About Regulatory Changes for Certain Biological Product Medications
- FDA Biosimilars Website
- The Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
- Archived copy of the Orange Book on March 20, 2020 (PDF - 10 MB)
- Biologics License Applications and Master Files, A Proposed Rule by the Food and Drug Administration on 06/28/2019
- Changes that affect compounding as of March 23, 2020