Sandoz, a Novartis company, has became the first company to receive approval of a biosimilar in the U.S. through the new FDA biosimilar pathway established under the Biologics Price Competition and Innovation Act.

The FDA today approved Zarxio (filgrastim-sndz) for all indications included in the reference product’s (Neupogen) label. According to Sandoz, the approval was based on a comprehensive package of analytical, nonclinical and clinical data that confirmed 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). It also paves the way for greater access to high-quality biologics in the U.S.

“The FDA approval of Zarxio marks a significant milestone for the U.S. healthcare system and for patients who might suffer from neutropenia,” said Carol Lynch, global head of biopharmaceuticals and oncology injectables at Sandoz. “As the global leader in biosimilars, we are honored to be the first company to successfully work with the FDA to navigate the U.S. biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the U.S.”

“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 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 v. 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 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. According to the company, it has over 50% volume share of biosimilars approved in North America, Europe, Japan and Australia. Sandoz currently markets three biosimilars (somatropin, filgrastim and epoetin alfa) outside the U.S.; each occupies the top biosimilar position in its respective category. The Sandoz pipeline has several biosimilars across various stages of development, including five programs in phase III clinical trials/filing preparation.

Neutropenia is a condition characterized by a low amount of neutrophils in the 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.

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 $9.6 billion. Sandoz is a global leader in biosimilars, generic anti-infectives, ophthalmics and transplantation medicines. In addition, it focuses on 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 its portfolio is in differentiated products—scientifically more difficult to develop and manufacture than standard generics. In addition to organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, it has had a series of targeted acquisitions, including Hexal (Germany), EBEWE Pharma (Austria) and Fougera Pharmaceuticals (U.S.).

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