The Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated pathway for companies to bring biologic drugs to market that are “biosimilar” to previously approved branded reference products by relying on clinical studies that were performed by the reference product sponsor (RPS).
This note introduces biosimilars, the litigation process set up by the BPCIA to facilitate resolution of patent disputes between reference product sponsors and biosimilar manufacturers, and touches on related trends, such as the potential use of inter partes review proceedings by biosimilar manufacturers as an alternative or in addition to litigation.
