The FDA Approves Zarxio Opening the Door to the U.S. Biosimilars Market

Fitzpatrick Case Update
March 6, 2015

March 6, 2015 was a turning point for the emerging U.S. biosimilars market. The U.S. Food and Drug Administration (FDA) approved Sandoz’s application to market Zarxio®, the first biosimilar drug in the U.S. Zarxio® (approved as “filgrastim-sndz”) is a biosimilar of Amgen’s Neupogen®, a drug with 2013 sales of $1.4bn. Zarxio® is currently on the market in Europe (as Zarzio®), and is now approved in the U.S. as a 0.5 ml and a 0.8 ml injectable for all five of the indications on the Neupogen® label, including the treatment of patients with various cancers, and the treatment of patients with various forms of neutropenia (white blood cell disorders).

View Attachment (PDF)