Biologics Price Competition and Innovation Act of 2009

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ucm216146.pdf

The Biologics Price Competition and Innovation Act of 2009 (BPCIA)—a provision in the Patient Protection and Affordable Care Act—was signed into law by President Obama on March 23, 2010. The stated purpose of the legislation is to establish “a biosimilars pathway balancing innovation and consumer interests.” The BPCIA amends Section 351 of the Public Health Service Act to include an abbreviated process for the Food and Drug Administration (FDA) to approve follow-on versions of originator biological products, much as the Hatch-Waxman Amendments of 1984 created an abbreviated pathway for generic copies of drugs with approved New Drug Applications.

In addition to creating the 351(k) pathway for licensure of biosimilars, the BPCIA:

  • Details the information required for a biological product to be deemed biosimilar.
  • Introduces standards for determining interchangeability of a biosimilar and its reference product (i.e., instances in which a pharmacist may substitute a biosimilar for the reference product without the intervention of the health care provider who prescribed the reference product).
  • Establishes a 12-year period of exclusivity for the initial reference product (i.e., before any biosimilar application may be approved) as well as an exclusivity period for the first biosimilar determined to be interchangeable with a particular reference product.
  • Outlines a process to litigate patent issues.
  • Defines incentives to encourage pediatric studies.