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Neupogen News

FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen

Posted 21 Jul 2018 by Drugs.com

July 20, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product. “The FDA approval of Nivestym marks an important step in helping expand access to critical treatment options for patients with neutropenia, m ...

FDA Approves First Biosimilar Product Zarxio (filgrastim-sndz)

Posted 6 Mar 2015 by Drugs.com

March 6, 2015 – The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that it ...

Biosimilars in 2015 - What Can We Expect?

Posted 7 Jan 2015 by Drugs.com

On Wednesday, January 7th, the FDA Oncologic Drugs Advisory Committee unanimously recommended approval of Sandoz’s EP2006, a biosimilar for filgrastim (Neupogen). EP2006 is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments that deplete these necessary infection-fighting cells. If FDA-approved, this would be the first true biosimilar in the ...

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Related Condition Support Groups

Neutropenia, Neutropenia Associated with Chemotherapy, Bone Marrow Transplantation, Neutropenia Associated with Radiation, Peripheral Progenitor Cell Transplantation

Neupogen Patient Information at Drugs.com