By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA


Biological products have historically been approved under two laws: The Public Health Service Act (PHS Act) through a Biologics License Application (BLA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) through a New Drug Application (NDA). Biological products are “licensed” under the PHS Act and “approved” under the FD&C Act. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) mandated that biological products  previously submitted under  the FD&C Act be submitted under the PHS Act. March 23, 2020 is the transition date upon which this will occur.

Many of the applications for therapeutic biological products are licensed under the PHS ACct, but there are some protein products that have historically been  filed under the FD&C Act. The BPCI Act notes that protein products will be regulated by amending the definition of a biological product that was outlined in the PHS Act to also describe “a protein (except any chemically synthesized polypepetide).” Protein products that will transition from the FD&C Act to the PHS Act include insulin and insulin analogs, human growth hormone, and reproductive hormones.

With regard to proposed biological products, the BPCI ACT entails the potential approval pathways for submitting a marketing application that may be impacted by this transition in acts. After March 23, 2020, sponsors intending on submitting their biological products under section 505 in the FD&C Act will now need to be submitted under the PHS Act section 351. This needs to be filed as either a 351(a) BLA, which is known as a stand-alone BLA, or a 351 (k) BLA that is for a proposed biosimilar product or a proposed interchangeable product.

Conversely, for the approved products, the BPCI Act dictates that for a marketing application that was approved as a biological product based on section 505 of the FD&C Act will be considered as a license for the biological product, essentially an approved BLA following the section 351 of the PHS Act.

Beginning on March 23, 2020, the BPCI Act demands that an approved marketing application for a biological product filed under 505 section of the FD&C Act will be licensed as a biological product following the 351 section for the PHS Act. Additionally, the transition period of 10 years lasting from March 23, 2010 to March 23, 2020, allowed sponsors of biological products that are impacted by this change to prepare for these modifications and any applications for biological products filed under section 505 for the FD&C Act to be approved prior to March 23, 2020.

The FDA is attempting to be as accommodating as possible to ensure that this transition does not negatively impact any manufacturer or patient related to these biological products. Additional resources for specific situations can be consulted and reviewed:  Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009, The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers, Definition of the Term “Biological Product,” Responsibility in OPQ for the Integrated Quality Assessment of Products Containing Drug Substances Composed of Amino Acid Polymers, and Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020.



At HartmannWillner LLC we understand the regulatory requirements for development of biological products through the BLA and NDA route. With our help, you can transition  your approved biologic to a licensed biologic. Contact us today to learn more about our services and how we can help you.

Suzanne M. Sensabaugh has advanced the development of over 130 biologics, biosimilars, and combination products since 2009. She can be reached at