Annals of Oncology (09/01/2015) Blackwell, K.; Semiglazov, V.; Krasnozhon, D.

A recent Phase III study sought to compare the biosimilar filgrastim (EP2006) with Neupogen, its U.S.-licensed reference product, in breast cancer patients receiving (neo)adjuvant myelosuppressive chemotherapy. More than 200 patients receiving filgrastim 5 mcg/kg/day over six chemotherapy cycles were randomized into four groups: two that received only the biosimilar or reference drug, and two that received alternating treatments during each cycle. According to the data, the duration of severe neutropenia in cycle 1—the primary endpoint—was 1.17 days in the biosimilar group and 1.20 in the reference group, demonstrating the noninferiority of the biosimilar compared with the reference. There were no clinically meaningful differences seen in terms of incidence of febrile neutropenia (FN), hospitalization due to FN, incidence of infections, depth and time of absolute neutrophil count (ANC) nadir, and time to ANC recovery during cycle 1 and in all cycles. The findings show that the biosimilar and reference product are similar, with no significant differences relating to efficacy and safety in the prevention of severe neutropenia. The authors suggest that "biosimilar filgrastim could represent an important alternative to the reference product."

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