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
WASHINGTON — Zarxio (filgrastim), a cancer treatment from Sandoz Inc., has become the first biosimilar product approved in the United States. The Food and Drug Administration announced its approval of Zarxio, a biosimilar to Neupogen, an oncology product from Amgen Inc., on Friday. The move is being hailed as a watershed event that paves the
The National Council for Prescription Drug Programs took part in the meeting that may result in the rollout of the nation’s first biosimilar medication. John Klimek, senior vice president for standards and industry information technology at NCPDP, addressed the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and Oncologic Drugs Advisory Committee (ODAC)
