Background: Chemotherapy-induced neutropenia is a common result of myelosuppressive chemotherapy treatment.\nInfections such as febrile neutropenia (FN) are sensitive to the duration of neutropenia as well as the depth of\nabsolute neutrophil count (ANC) at nadir. Filgrastim, a granulocyte colony stimulating factor (G-CSF), can stimulate\nthe function of mature neutrophils. Pegfilgrastim, a long-acting form of filgrastim, has been shown to reduce FN to a\ngreater extent compared to filgrastim. G-CSF agents have been recommended for prophylactic administration with\nchemotherapy. Apotex developed a proposed pegfilgrastim biosimilar. This study was conducted to confirm that\nno clinically meaningful efficacy or safety differences exist between Apotexâ??s proposed biosimilar and its reference\nproduct.\nMethods: 589 breast cancer patients were randomized and dosed with the proposed pegfilgrastim biosimilar, USlicensed\npegfilgrastim reference product, or EU-approved pegfilgrastim reference product. The primary endpoint\nassessed was the duration of severe neutropenia (DSN) and secondary endpoints included rate of FN and ANC nadir.\nResults: Data showed that the mean DSN, the primary endpoint measured, was comparable across all three treatments.\nThe As Treated arm had a 95% confidence interval within the equivalence range for the proposed pegfilgrastim\nbiosimilar with the US-licensed and EU-approved pegfilgrastim reference products. Secondary endpoints, which\nincluded depth and peak of ANC nadir, time to ANC recovery post-nadir and rates of FN, also showed similarity\nbetween the three different treatment groups. The adverse event incidence was similar across treatment arms and\nthere were no unexpected safety events.Conclusions: Overall, these results show that the proposed pegfilgrastim biosimilar is similar to Amgenâ??s US-licensed\nand EU-approved pegfilgrastim reference products with regard to the clinical efficacy and safety endpoints assessed.
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