Supreme Court to Decide on 180-Day Biosimilar Exclusivity, Early Notification

The U.S. Supreme Court is expected to rule by the end of June on a case that could affect how long it takes biosimilars to get to market.

The court heard oral arguments centering on the FDA’s March 2015 approval of the first biosimilar product, Zarxio (filgrastim-sndz), generics-maker Sandoz’s version of Amgen’s Neupogen, which stimulates growth of white blood cells.

A key issue in the case is whether a biosimilar applicant must provide the reference product’s manufacturer a copy of their aBLA after it has been accepted for FDA review. Another is whether a 180-day countdown, required before marketing, can begin before the agency approves the biosimilar.

The Biologics Price Competition and Innovation Act — the part of the Affordable Care Act establishing the FDA’s biosimilar pathway — says an applicant “shall provide” copies of their application to the reference holder. Sandoz didn’t do that, so Amgen sued.