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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 is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and c ... Read more

Related support groups: Neupogen, Neutropenia, Neutropenia Associated with Chemotherapy, Filgrastim

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 U.S. and would have a brand name of Zarzio. The FDA noted in their briefs that EP2006 was “highly similar” to the brand biologic and had “no clinically meaningful differences between the proposed product and the reference product in terms of safety, purity, and potency”. The FDA stated that “robust” pharmacokinetic and pharmacodynamic comparative studies supported biosimilarity with the original filgrastim. Legal action over patent protection may still interfere with a launch any time soon. I’ ... Read more

Related support groups: Neupogen, Filgrastim

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) and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow. This reduction in neutrophils may lead to infection and fever (febrile neutropenia). Tbo-filgrastim stimulates the bone marrow to increase the production of neutrophils. It is administered as an injection beginning 24 hours after chemotherapy treatment. “Supportive care products, such as tbo-filgrastim, reduce or allow for more rapid recovery from side effects of cancer tre ... Read more

Related support groups: Neutropenia, Neutropenia Associated with Chemotherapy, Filgrastim

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 malignancies) and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow. This reduction in neutrophils may lead to infection and fever (febrile neutropenia). Tbo-filgrastim stimulates the bone marrow to increase the production of neutrophils. It is administered as an injection beginning 24 hours after chemotherapy treatment. “Supportive care products, such as tbo-filgrastim, reduce or allow for more rapid recovery from side effects of cancer tre ... Read more

Related support groups: Neulasta, Neutropenia, Filgrastim

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Further Information

Related Condition Support Groups

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

Related Drug Support Groups

Neupogen, Zarxio

Filgrastim Patient Information at Drugs.com