Sandoz, a Novartis company, announced that the US Food and Drug Administration (FDA) approved Zarxio (filgrastim-sndz) for all indications included in the reference product’s label.

Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The approval was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar to the US-licensed reference product. The approval of Zarxio follows the unanimous positive vote in January by the Oncologic Drugs Advisory Committee (ODAC).

“The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia,” said Carol Lynch, Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz. “As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US.”

“Filgrastim has proven clinical value in treating patients at increased risk of neutropenia, but it is underused in the US for a variety of reasons, including price” said Dr. Louis Weiner, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University. “Biosimilars have the potential to increase access and the approval of Zarxio may reduce costs to the healthcare system. The comprehensive data set supports its use in clinical practice.”

Marketed as Zarzio® outside of the US, the Sandoz biosimilar filgrastim is available in more than 60 countries worldwide, has generated over 7.5 million patient-days of exposure and is the most widely used filgrastim in Europe.

Source: Sandoz press release.