On February 20, 2020 the U.S. Food and Drug Administration (FDA) published a final rule, revising the regulatory definition of biological products to match the definition Congress agreed to in the Further Consolidated Appropriations Act, 2020.  The changes reflect the FDA’s efforts to remove regulatory hurdles in order to create cheaper versions of biological products, most notably insulin.


Biological products, or biologics, replicate natural substances in the body, like enzymes, antibodies, or hormones.  Insulin products have received particular attention, as many rely on insulin to manage their condition.  However, despite the wide-spread demand for insulin products, there has been limited competition in the marketplace, resulting in fewer options for consumers and increasingly higher prices.

The Public Health Service Act (PHS Act) requires those who manufacture biologics to hold a license for the products, which are issued by FDA.  The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amended the PHS Act to include an abbreviated licensure pathway for biologics that were biosimilar or interchangeable with an FDA-licensed product.  Before the BPCI Act, certain protein biologics like insulin were approved under the Food, Drug and Cosmetic Act (FDC Act).  The BPCI Act amended the PHS Act to provide that on March 23, 2020, all licenses for these “transition” biologics previously approved under the FDC Act would be deemed licensed under the PHS Act.  This transition would make the PHS Act the exclusive pathway for biologic approval.

Changes to Biologics Regulation

The final rule amends FDA’s regulatory definition of “biological product,” by finalizing a technical revision and conforming to the statutory definition in the BPCI Act.  Under the final rule, the definition of “biological product” includes all proteins, meaning “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.”  The final rule is intended to “reduce regulatory uncertainty over whether certain products are regulated as drugs or biological products.”

Starting March 23, 2020, an application for a biological product formerly approved under the FDC Act, such as insulin, will be deemed to be a license application for the product under the PHS Act.  Regulation of these transition biologics as biological products, rather than as approved drugs, will enable them to serve as the reference product for biosimilar or interchangeable products under the abbreviated licensure pathway of the BPCI Act.  Biosimilars approved under the PHS Act will be able to seek interchangeable designations for the first time, and interchangeable insulins will be eligible for substitution at the pharmacy level.  With increased availability of approved biosimilar and interchangeable insulin products, FDA anticipates patient access and affordability to improve.

In a press release, FDA stated the new rule is “aimed at increasing patient access to insulin products used daily by millions of Americans… as well as certain other biological products set to transition regulatory pathways in March.”

FDA published information for providers and patients about these changes, addressing frequently asked questions.  These documents emphasize that the transition will not impact existing prescribing or dispensing practices or product appearance.