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news.Generic pharmaceutical company Sandoz’s Zarxio has received an US Food and Drug Administration (FDA) approval for all indications included in the reference product's label.
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Sandoz, a Novartis company, is the first in the US to receive the approval through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.
The company was given the approval following a comprehensive package of analytical, nonclinical, and clinical data to confirm that Zarxio was highly similar to the US-licensed reference product.
Sandoz global head of biopharmaceuticals and oncology injectables Carol Lynch said: "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."
In the study to prove the product’s similarity to the reference product, it was found that both produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy.
Chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University Louis Weiner 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."