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    Home > Active Ingredient News > Immunology News > Sword refers to the heavy weight of the "white" medicine! Pfizer biosimilar Nyvepria (Pifegsting) approved by the U.S. FDA!

    Sword refers to the heavy weight of the "white" medicine! Pfizer biosimilar Nyvepria (Pifegsting) approved by the U.S. FDA!

    • Last Update: 2020-06-16
    • Source: Internet
    • Author: User
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    JUNE 12, 2020 /PRNewswire/ -- Pfizer has announced that the U.SFood and Drug Administration (FDA) has approved Nyvepria (pegfilstim-apgf, Perfiertin), a biosimilar to the heavy-duty "litre white" brand Neulasta(pegfilstim, Piffesting)Nyvepria is suitable for reducing the incidence of febrile neutrophils, one of the most serious side effects of many types of chemotherapy, which reduces the ability of cancer patients to fight infectionIn July 2018, Pfizer's other biosimilar, Nivestym (filgrastim-floti), was approved by the U.SFDA as a biosimilar to Thein's "rising white" brand drug NeupogenThe FDA's approval of Nyvepria is based on a review of a comprehensive packet and all the evidence that Nyvepria is highly similar to the reference product NeulastaPfizer has also submitted a listing application to the European Medicines Agency (EMA) for the pegfilgrastim biosimilar, which is currently under reviewAndy Schmeltz, Pfizer's global president of oncology, said: "FDA approval of Nyvepria is a positive step that can both save costs and increase access to important treatmentoptionsWe are proud to add this new, long-term supportive care approach to our strong portfolio, and there are now six FDA-approved cancer biosimilars, three of which are specifically approved for supportive care for cancer patientsWe look forward to providing Nyvepria to U.Spatients and doctors later this yearAli McBride, former president of the Community Cancer Centres Association (ACCC), said: "Chemotherapy-induced hyperthermia is a more common and serious side effect in some cancer treatments, which can lead to serious complications and changes in treatment optionsThe FDA's approval of Nyvepria will provide clinicians with an additional long-term treatment that can help prevent infection in patients with bone marrow-suppressive chemotherapy"Biosimilars play an important role in cancer treatment or supportive care, both in increasing patients' access to essential medicines and in delivering value to the healthcare system by driving market competition and reducing care costs." With more than a decade of global market experience in biosimilars, nine approved biosimilar portfolios in the United States and the broadest portfolio of biosimilars supporting tumor therapy, Pfizer is proud to be a global leader in biosimilars and a leader in this important healthcare sectorPegfilgrastim (Pifgstin) is a long-lasting version of filgrastim (non-gsting, recombinant human granulocytopha cluster irritant s(G-CSF) that extends the drug's metabolic time in the body with polyethylene glycol (PEG) modification, with better efficacyBoth are "whitening" drugs used to increase the number of white blood cells in the patient's bodyG-CSF is mainly used clinically to prevent and treat leukocyte reduction caused by tumor radiotherapy or chemotherapy, treatment of bone marrow hematopoietic dysfunction and bone marrow hyperplasia syndrome, prevention of potential infection complications of leukocyte reduction, and accelerated recovery of neutrophil reduction caused by infection After radiotherapy or chemotherapy, cancer patients often experience symptoms such as reduced white blood cells and reduced resistance to infection As a result, the clinical use of "white-white medicine" to increase the number of white blood cells in the patient's body Neutrophila is one of the most serious side effects of chemotherapy Studies have shown that 4,000 cancer patients in the United States die each year from febrile neutrophil reduction and 60,000 are hospitalized for neutrophil anolysis Biosimilars are expected to save up to $54 billion over the next decade for the U.S health care system, which is in urgent need of more neutrophil reduction treatments, as cancer-related neutrophil synopsis costs up to $2.3 billion a year According to the FDA's Biosimilars Database, the agency has so far approved two non-Gstin biosimilars: Nivestym (filgrastim-aafi, July 2018, Pfizer), Zarxio (filgrastim-sndz, March 2015, Sanders) In addition, the FDA has approved four biosimilars of Pegegrstin, namely, Nyvepria (pegfilastim-apgf, June 2020, Pfizer), And Fulfila (pegfilastim-jmdb, June 2018) Mylan, Udenyca (pegfilgrastim-cbqv, November 2018, Coherus BioSciences), Ziextenzo (pegfilastim-bmez, November 2019, Sanders) ( Original source: FDA approves Pfizer's Oncology Supportive Care Bioco, NYVEPRIA (pegfilgrastim-apgf)
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