Biosimilar Litigation: Lessons So Far

Congress enacted the Biological Price Competition and Innovation Act (BPCIA) in March 2010, as part of the Affordable Care Act, creating an abbreviated FDA-approval pathway for biological products demonstrated to be "biosimilar" or "interchangeable" with a licensed biologic. The BPCIA sets forth detailed procedures for exchanging patent information between an applicant who files an abbreviated biologics license application (aBLA) under the BPCIA (referred to as a "subsection (k) applicant") and the reference product sponsor (RPS). The statute also provides for a "notice of commercial marketing," whereby the subsection (k) applicant "shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k)." With FDA's approval of the first biosimilar product—Sandoz's Zarxio, a biosimilar to Amgen's Neupogen (filgrastim)—earlier this year, litigants are raising