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Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: Results of a randomized, double-blind phase III clinical study vs reference pegfilgrastim in patients with breast cancer receiving chemotherapy

BMC Cancer Feb 13, 2019

Kahan Z, et al. - A sum of 239 females were randomized to assess the efficiency and safety of RGB-02 (Gedeon Richter) (biosimilar to pegylated G-CSF (Neulasta, Amgen) in breast cancer cases experiencing a cytotoxic regimen. They recorded 1.7 (RGB-02) and 1.6 days (reference), with a difference (LS Mean) of 0.1 days, the mean duration of severe neutropenia in Cycle 1. They noticed comparable effectiveness and safety profiles of the once-per-cycle administration of RGB-02 and the pegfilgrastim reference as no clinical variation was noted in secondary endpoints too.
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