NEW YORK — Sandoz has inaugurated a new era in medicine with the release of Zarxio, the first biosimilar of a biologic drug approved in the United States.
The Novartis subsidiary said Thursday that Zarxio — a biosimilar of Amgen Corp.’s oncology drug Neupogen, which boosts white blood cells — would broaden access to an important treatment by offering a “high-quality, more affordable version.”
Amgen had tried to stop the sale of Zarxio, also known as filgrastim-sndz, but the Washington-based appeals court rejected its attempt to block the launch.
Biosimilars have been on the market in Europe since 2006. However, the U.S. regulatory pathway for biosimilars, which are made in living cells and can never be exact replicas of originals, was only established by health care reform in 2010.
“As the pioneer and global leader in biosimilars, Sandoz has maintained a commitment to bringing high-quality biosimilar medicines to patients and health care professionals around the world,” Richard Francis, global head of Sandoz, said in a 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 launch follows Food and Drug Administration approval of Zarxio on March 6. Made via the new biosimilars pathway established under the Biologics Price Competition and Innovation Act, the approval was based on a comprehensive package of analytical, nonclinical, and clinical data.
“While biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the health care budget in general,” explained Dr. Ralph Boccia, medical director of the Center for Cancer and Blood Disorders and chief medical officer for the International Oncology Network (ION). “Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies.”
With the launch of Zarxio, Sandoz also announced Sandoz One Source, a patient support center designed to connect patients to the information and resources they need.