03.09.15
Sandoz, a Novartis company, received approval from the FDA for Zarxio a biosimilar of filgrastim (Amgen’s Neupogen) for all indications included in the reference product’s label. Sandoz is the first company to receive approval of a biosimilar in the U.S. through the new biosimilars pathway established under the Biologics Price Competition and Innovation Act.
The approval was based on analytical, nonclinical, and clinical data, confirming that Zarxio is highly similar to the U.S.-licensed reference product, which is indicated for use in neutropenia, acute myeloid leukemia, cancer patients receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment.
The successful head-to-head PIONEER study demonstrated high similarity sufficient to allow the use of Zarxio in all indications of the reference product and produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy. No immunogenicity or antibodies against rhG-CSF were detected throughout the study.
“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 U.S. biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US.”
Marketed as Zarzio outside of the U.S., the Sandoz biosimilar filgrastim is available in more than 60 countries worldwide.
The approval was based on analytical, nonclinical, and clinical data, confirming that Zarxio is highly similar to the U.S.-licensed reference product, which is indicated for use in neutropenia, acute myeloid leukemia, cancer patients receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment.
The successful head-to-head PIONEER study demonstrated high similarity sufficient to allow the use of Zarxio in all indications of the reference product and produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy. No immunogenicity or antibodies against rhG-CSF were detected throughout the study.
“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 U.S. biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US.”
Marketed as Zarzio outside of the U.S., the Sandoz biosimilar filgrastim is available in more than 60 countries worldwide.