Febrile Neutropenia: FDA Approves Pegfilgrastim Biosimilar

The FDA has now approved pegfilgrastim-apgf (NyvepriaTM, Pfizer), a biosimilar of pegfilgrastim (Neulasta®, Amgen), for the prevention of febrile neutropenia in patients receiving myelosuppressive treatment for non-myeloid cancers. For patients with non-myeloid malignancies, chemotherapy and other anti-cancer medicines can often result in neutropenia, a condition involving an abnormally low number of neutrophils––a type of white blood cell––which increases the chance of life-threatening infectio...
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Pegfilgrastim Biosimilar One Step Closer to FDA Approval

The pharmaceutical company Sandoz recently resubmitted its Biologics License Application to the FDA for a proposed pegfilgrastim biosimilar. Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia, a side effect of chemotherapy that kills 4,000 cancer patients every year in the United States. A biosimilar is a drug made up of living organisms that is "similar" to another biologic medicine (considered to be the reference product) that is already FDA approved. A ...
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