Hold your biosimilar horses.
A judge has temporarly blocked the sale of Sandoz's biosimilar version of Amgen Inc,'s drug Neupogen.
Approved by the FDA in March, and the drug is the first biosimilar to be sold in the U.S., but a U.S. Court of Appeals for the Federal Circuit issued an injunction preventing the sale until the court resolves a pending appeal over the medication's release, reported The Recorder.
"In seeking the injunction from the Federal Circuit, lawyers for Amgen argued that the case presents issues of first impression under the 2010 Biologics Price Competition and Innovation Act, which created a new pathway for the approval of biosimilar products," wrote The Recorder. "Argument is set for June 3."