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Zarxio from Sandoz (Novartis) Receives First FDA Biosimilar Approval

In a March 6, 2015 press release, Sandoz, a Novartis company, announced that the U.S. 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 U.S. 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 U.S.-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 Dr. 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 U.S. 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 U.S. 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." The successful Sandoz pivotal head-to-head PIONEER study was the final piece of data contributing to the totality of evidence used by the 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 (1.17 and 1.20 days for Zarxio and the reference product, respectively). The mean time to absolute neutrophil count recovery in cycle 1 was also similar (1.8 days ± 0.97 in ZARXIO arm vs 1.7 days ± 0.81 in reference product arm). No immunogenicity or antibodies against rhG-CSF were detected throughout the study.

Neutropenia is a condition characterized by a low amount of neutrophils in your blood - one of the most common types of white blood cells - whose role is to protect the body from infections. Neutropenia occurs often following cancer treatments, as well as advanced HIV infections. Filgrastim is a naturally occurring protein produced commercially by recombinant DNA technology, which stimulates production of white blood cells.

Marketed as Zarzio® outside of the U.S., 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. Sandoz is the global market leader with over 50 percent volume share of biosimilars approved in North America, Europe, Japan, and Australia.

Sandoz currently markets three biosimilars (somatropin, filgrastim, and epoetin alfa) outside the US; each of which occupies the #1 biosimilar position in its respective category. The Sandoz pipeline has several biosimilars across the various stages of development, including five programs in Phase III clinical trials/filing preparation - more than any other company in the industry.

Note that very important safety information for Zarzio is provided in the remainder of the press release, which is provided in its entirety at the link below.

[Press release]

http://www.novartis.com/newsroom/media-releases/en/2015/1900097.shtml

http://www.raps.org/uploadedImages/Site_Setup/Regulatory_Focus/News/2014...