180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction -

Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) -

A year after analyzing the patent dance and notice requirements of the Biologics Price Competition and Innovation Act (BPCIA) in Amgen Inc. v. Sandoz Inc., the US Court of Appeals for the Federal Circuit has ruled that a follow-on biologic or biosimilar applicant is always required to provide a 180-day notice of marketing to the reference product sponsor (RPS) after the biosimilar product is licensed by the US Food and Drug Administration (FDA). Amgen Inc., v. Apotex Inc., Case No. 2016-1308 (Fed. Cir. July 5, 2016), (Taranto, C.J.).

BPCIA Background -

The BPCIA allows biosimilar applicants to gain approval for a drug that is biosimilar to a reference product without repeating all of the testing done by the original RPS. Instead the biosimilar applicant can use publicly available information about the reference product’s safety, purity and potency in support of the application. In order to balance innovation with consumer interests, the BPCIA prohibits a biosimilar application from being submitted until four years after the reference product was licensed, and prohibits biosimilar approval until 12 years after the reference product was licensed.