On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act. The Affordable Care Act contains a subtitle “Biologics Price Competition and Innovation Act of 2009” (BPCI Act) with information that establishes an abbreviated approval pathway for biologic products that are shown to be “highly similar” to or “interchangeable” with an FDA-licensed biological product.
A biologic agent is a product derived from living sources, such as viruses, bacteria, or human and other animal sources. General classes of biologic agents include monoclonal antibodies, complex sugars, blood derivatives, vaccines, and recombinant or purified proteins such as cytokines, thrombolytic agents, and enzymes. The objectives of the BPCI Act are conceptually similar to those of the Drug Price Competition and Patent Term Restoration Act of 1984 (commonly referred to as the Hatch-Waxman Act), which established abbreviated pathways for the approval of drug products (i.e., “generics”) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The BPCI Act aligns with the FDA's longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. However, biologic agents can present challenges to implementing an abbreviated approval pathway for many reasons. First, biologics are considerably more complex than most chemical entities due to increased molecular weight, complicated and patented manufacturing processes, immunogenicity issues, and analytical issues related to determining properties unique to these agents. Second, the clinical consequences of subtle differences in biosimilar products may vary; therefore, assessment on an individual product basis is warranted.