Novartis subsidiary Sandoz has received approval from the US Food and Drug Administration (FDA) for its Zarxio (filgrastim-sndz) for all indications included in the reference product’s label.
Novartis noted that Sandoz is the first firm to secure approval of a biosimilar in the US through the new FDA biosimilars pathway created under the Biologics Price Competition and Innovation Act.
Sandoz biopharmaceuticals and oncology injectables global head 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 honoured 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."
FDA approva wasl based on pivotal head-to-head Pioneer study, which demonstrated high similarity to all indications of the reference product.
According to Novartis, Zarxio and the reference product both produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy, in the Pioneer study.
Neutropenia is a condition characterised by a low amount of neutrophils in the blood, one of the most common types of white blood cells that protect the body from infections.
Sandoz biosimilar filgrastim, which is marketed as Zarzio outside the US, is available in around 60 countries worldwide.
Sandoz has several biosimilars in various stages of development, comprising five programmes in Phase III clinical trials/filing preparation.
Image: Blood film with a striking absence of neutrophils, leaving only red blood cells and platelets. Photo: courtesy of Roberto J Galindo.
