FDA Approves First US Biosimilar But Court Action Could Delay Market Entry

On March 6, 2015, the United States FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the US. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen (filgrastim), which the agency originally licensed in 1991. Although Sandoz has been selling its biosimilar Neupogen in Europe (where it is called Zarzio) since 2009, it did not file an application to market the product in the US until last July. In taking only eight months to review Sandoz’s application, the agency made good on its stated goal of making a decision on the first biosimilar filings within 10 months.

In this alert, Timothy J. Shea, Jr. explains the impact of the approval of Zarxio as the first US biosimilar, and the remaining legal considerations before it becomes available to the public. Download the attached PDF to read the full alert.