Sandoz announced that Zarxio (filgrastim-sndz), the first biosimilar approved by the FDA in March, is now available in the United States. The biosimilar was approved via the biosimilars pathway established under the Biologics Price Competition and Innovation Act.
“As the pioneer and global leader in biosimilars, Sandoz has maintained a commitment to bringing high-quality biosimilar medicines to patients and healthcare professionals around the world,” said Richard Francis, global dead of Sandoz, in a press statement. “With the launch of Zarxio, we look forward to increasing patient, prescriber, and payor access to filgrastim in the U.S. by offering a high-quality, more affordable version of this important oncology medicine.”
The biosimilar was approved based on a comprehensive package of analytical, nonclinical, and clinical data, confirming that it is highly similar to the U.S.-licensed reference product, 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 the reference product. Importantly, the data demonstrating high similarity was sufficient to allow extrapolation of use of Zarxio to five indications of the reference products,” Sandoz noted.
Zarxio is indicated for patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy, and patients with severe chronic neutropenia.
For additional information, visit www.zarxio.com.