The FDA today approved ZarxioTM (filgrastim-sndz) for the treatment of neutropenia associated with chemotherapy. The approval includes all indications included in the reference product’s (Neupogen) label.

Sandoz, a Novartis company, thus became the first pharma firm 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.

“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

“The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia,” added Carol Lynch, global head of biopharmaceuticals and oncology injectables at Sandoz.

“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 Louis Weiner, M.D., 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.”

According to Sandoz, 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 Amgen’s Neupogen.The data demonstrating high similarity was sufficient to allow extrapolation of use of Zarxio to all indications of the reference product, added the Amgen official. 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.

As noted in a 2011 IMS report, “Shaping the Biosimilars Opportunity,” biosimilars are expected to increase their market share within biopharmaceuticals from 1% in 2014 to 10% by 2020, representing a market value increase from $1.9 billion to as much as $25 billion. Because the European Union has enjoyed a five to seven-year head start on issuing guidance related to biosimilar development, virtually all sales  have so far occurred occur in Europe. So the current score is: EMEA 21, FDA 1.








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