Sandoz launches first U.S. biosimilar Zarxio

HOLZKIRCHEN, Germany — Sandoz on Thursday announced that it had launched its Zarxio (filgrastim-sndz) injection, a biosimilar of Amgen’s Neupogen (filgrastim). The drug is the first biosimilar drug to launch in the U.S. Zarxio, intended to reduce risk of infection in patients with a low count of white blood cells, is available in boxes of 0.5- and 0.8-ml single-use injections. 

“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,” Sandoz’s global head Richard Francis said. “With the launch of Zarxio, we look forward to increasing patient, prescriber and payer access to filgrastim in the US by offering a high-quality, more affordable version of this important oncology medicine.”

Alongside Zarxio, Sandoz is launching is OneSource patient services center that will offer resources and information for patients. 

Though it was approved by the Food and Drug Administration on March 6, Sandoz fought an injunction by Amgen that prevented it from being sold. A July ruling resolved the case, saying that a company whose biosimilar has been approved by the FDA must give the original drug maker 180 days’ notice of commercial marketing before launch.

Thursday's launch was praised by the Generic Pharmaceutical Association’s Biosmilars Council. 

“The Biosimilars Council ... is very pleased that a federal appeals court has cleared the way for patients to access the first FDA-approved biosimilar,” the organization said. “The launch of Zarxio is a victory for all champions of improving access and affordability in healthcare.”