Posted from: Monday, October 05, 2015 - 04:34 PM - Present

Zarxio Approved as First U.S. Biosimilar

September 3, 2015 – Sandoz launched Zarxio (filgrastim-sndz) which is biosimilar to Amgen’s Neupogen (filgrastim) and indicated for cancer patients who receive myelosuppressive chemotherapy, patients who receive induction or consolidation chemotherapy for acute myeloid leukemia (AML), cancer patients who receive bone marrow transplants, patients who undergo collection of or treatment with autologous peripheral blood progenitor, cell and patients who have severe chronic neutropenia. Neupogen was subsequently approved for an additional indication for the treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS) in May 2015. Dosage forms available for Zarxio are 300mcg/0.5mL and 480mcg/0.8mL single use, prefilled syringes. Approved by the FDA as the first biosimilar, Zarxio is still to be considered a generic but it is not automatically interchangeable with its innovator brand, Neupogen. However, Sandoz is conducting switching studies that will support an interchangeable application in the future. 

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Last Updated Sunday, October 13, 2019 - 12:01 AM.