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Filgrastim News

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 ...

FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients

Posted 1 Sep 2012 by Drugs.com

August 29, 2012 – The U.S. Food and Drug Administration today approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils. Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers (non-myeloid malignancies) ...

FDA Approves tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients

Posted 29 Aug 2012 by Drugs.com

August 29, 2012 – The U.S. Food and Drug Administration today approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils. Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers (non-myeloid m ...

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Further Information

Related Condition Support Groups

Neutropenia Associated with Chemotherapy, Neutropenia, Bone Marrow Transplantation, Aplastic Anemia, Myelodysplastic Syndrome, Peripheral Progenitor Cell Transplantation, Neutropenia Associated with AIDS or Zidovudine, Neutropenia Associated with Radiation, Sepsis

Related Drug Support Groups

Neupogen, Zarxio

Filgrastim Patient Information at Drugs.com