FDA approves first biosimilar ZarxioTM (filgrastim-sndz) from Sandoz

NovartisSandoz, a Novartis company, announced today that the US Food and Drug Administration (FDA) approved Zarxio(TM) (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."

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 (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.

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. 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.

About Neutropenia

<> 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.

About Sandoz
Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe.

The Sandoz global portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines. In addition, Sandoz holds leading global positions in key therapeutic areas ranging from generic injectables, dermatology and respiratory to cardiovascular, metabolism, central nervous system, pain and gastrointestinal. Sandoz develops, produces and markets finished dosage form (FDF) medicines as well as intermediary products including active pharmaceutical ingredients (APIs) and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products - products that are scientifically more difficult to develop and manufacture than standard generics.

In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has consistently driven growth in selected geographies and differentiated product areas through a series of targeted acquisitions, including Hexal (Germany), EBEWE Pharma (Austria), and Fougera Pharmaceuticals (US).

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