Safe switch of treatment from the reference product to RGB-02, a proposed biosimilar pegfilgrastim: Analysis of the results of three clinical trials

Illes, A.; Perjesi, Luca; Horvat-Karajz, K.; Jeszenoi, N.; Aradi, I.; Singh, Nand K.; Mair, Stuart; Kahán, Zsuzsanna

doi:10.1093/annonc/mdy300.017

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“…In order to demonstrate clinical efficacy and safety of RGB-02, a prospective, randomized multicenter, double-blind study (study code RGB-02-101) was designed and performed in patients with the aim to show comparability with the originator product Neulasta. The study population, women with breast cancer receiving chemotherapy, was similar to all three efficacy studies conducted in support of the regulatory approval of Neulasta [48,49]. However, in order to have an even more homogeneous population for comparison, in line with the principles of biosimilar development, the study was restricted to patients with stage IIB/III disease, thereby excluding stage IV.…”

Section: Overview Of Clinical Efficacymentioning

confidence: 99%

RGB-02 (Biosimilar Pegfilgrastim) In The Treatment Of Chemotherapy-Induced Neutropenia

et al. 2019

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Pegfilgrastim is widely used for the prevention of chemotherapy-induced neutropenia. The development and use of biosimilar agents help to rationalize healthcare expenditure and improve access to modern therapies to all who need them. This review focuses on pegfilgrastims with important role in oncology supportive care. RGB-02 (Gedeon Richter) is a proposed biosimilar to pegylated granulocyte-colony stimulating factor (Neulasta R , Amgen) with sustained release properties. The clinical analyses in three randomized clinical studies provided comparative data between RGB-02 and Neulasta, in a Phase III study patients receiving docetaxel-doxorubicin chemotherapy treatment equivalence was found. No difference was detected in any safety measure including immunogenicity; treatment switch, from the reference product to RGB-02 proved safe. Long-acting pegylated filgrastim RGB-02 has successfully accomplished various steps of biosimilar development.

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Section: Overview Of Clinical Efficacymentioning

confidence: 99%