The market for "biosimilars"—generic versions of federal Food and Drug Administration (FDA) approved biological drugs—which is an over $100 billion industry, is rapidly growing. Indeed, it is expected to be the single fastest-growing biologics sector in the next five years. By some accounts, sales of biosimilars are expected to reach $6.22 billion by 2020 from $2.29 billion in 2015. See Press Release, Mkts. & Mkts., Biosimilars Market Worth $6.22 Billion by 2020 (July 16, 2015).
The Biologics Price Competition and Innovation Act (BPCIA) was enacted in March 2010 as part of the Patient Protection and Affordable Care Act. 42 U.S.C. § 262. It provides a pathway for the approval of biologics by the FDA based on similarity or interchangeability with a licensed biologic as well as specific procedures for patent dispute resolution and litigation between an innovator (known as the reference product sponsor, or RPS) and a biosimilar applicant. However, the complex and largely untested regulatory scheme under the BPCIA has a number of ambiguities that have left it susceptible to challenge.
This article discusses the BPCIA framework, recent jurisprudence under the BPCIA, and strategies for RPSs and applicants in light of ambiguities in the BPCIA framework.