The Novartis company Sandoz has become the first company with a biosimilar approved by the US Food and Drug Administration (FDA) after today’s approval of Zarxio, a treatment for neutropenia.

Sandoz is the first company to receive the approval of a biosimilar in the US through the new FDA biosimilars pathway established under Biologics Price Competition and Innovation Act (BPCIA), that provides an abbreviated route for biosimilar products to enter the market.
Zarxio (filgrastim-sndz) is designated for all indications included in the reference product’s label. 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).

Carol Lynch, Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz, stated: “The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia. 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.

The successful Sandoz pivotal head-to-head PIONEER study was the final piece of data contributing to the totality of evidence used by FDA to approve Zarxio as biosimilar to the reference product. Importantly, the data demonstrating high similarity was sufficient to allow extrapolation of use of Zarxio to all indications of the reference product. In the PIONEER study, Zarxio and the reference product both produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy. No immunogenicity was detected throughout the study.

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Dr. Louis Weiner, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University, said: “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. 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. Sandoz has a commitment to increasing patient access to high-quality biosimilars.

With several biosimilars in its pipeline, more than any other company in the industry, Sandoz’s job in US has just begun.

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