Solicitor general asks SCOTUS to review biosimilar ruling

In an amicus brief filed to the U.S. Supreme Court, acting U.S. Solicitor General Ian Gershengorn recommended that the court review a lower court's decision preventing the launch of a biosimilar until 180 days after FDA approval. The Solicitor general argued that the six-month delay was not intended by the U.S. Congress when it passed the Biologics Price Competition and Innovation Act (BPCIA).

The U.S. Court of Appeals for the Federal Circuit (CAFC) had considered the specific intent of language in the law requiring a biosimilar's sponsor to give the manufacturer of its reference product 180-day notice before marketing the biosimilar. In July 2015, CAFC ruled that the notice can be given only after FDA has approved the biosimilar's BLA. The ruling delayed the launch of Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN). Zarxio is a biosimilar of Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, July 21, 2015). ...