On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. 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.

Biosimilar but Not Interchangeable -

Zarxio is approved for the same indications as Neupogen. However, because the FDA deemed Zarxio to be biosimilar to, but not interchangeable with, Neupogen, its use in patients must be prescribed by a health care professional. Under the Biologics Price Competition and Restoration Act of 2009 (“BPCIA”), which established the biosimilar approval pathway in the US, only biologic products that meet the heightened criteria for “interchangeability” may be substituted for the reference product at the pharmacy level without the intervention of the healthcare provider who prescribed the reference product...