First-Ever US Biosimilar Rx Approved

Peoples Rx owner says Zarxio, biosimilar to Neupogen, could reduce costs for patients

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) today approved the first biosimilar medication in United States history.

That medication is Zarxio (filgrastim-sndz). The pharmaceutical company Sandoz, a division of Novartis, produces Zarxio, which is biosimilar to Amgen's Neupogen (filgrastim).

When a medication is biosimilar to another, that means it mimics the effects, safety and effectiveness of a medication but is derived from living organisms like animals, yeast or even humans.

According to a Novartis press release, biosimilar medications may be less expensive than their non-biosimilar counterparts, which could increase patient access to these treatments.

"If Novartis is correct, Zarxio and similar biosimilar medications could reduce health care costs for thousands of patients across the US," said Bill Swail, RPh, owner of Peoples Rx Pharmacy in Austin, TX, in an interview with dailyRx News.

In Zarxio's case, the FDA approved it to treat patients with cancer who are undergoing chemotherapy or those with severe chronic neutropenia. Neutropenia is a disorder marked by an abnormally low white blood cell count.

The FDA approved Zarxio after animal and human studies found it to be safe, effective and similar to Neupogen. Side effects may include aching bones, swelling, wheezing, spleen rupture and allergic reactions.

Review Date: 
March 6, 2015
Last Updated:
March 10, 2015