Revista estadounidense de administración avanzada de fármacos Acceso abierto

Abstracto

A Randomized Open Label Parallel Design Clinical study of Rosastim, the Biosimilar Granulocyte Colony-stimulating Factor, for Chemotherapy-induced Neutropenia

Mehdi Mohammadzadeh, Tayebeh Ghari, Hamid Rezvani, Babak Salimi, Najva Kashani and Mahindokht Sayadinia

Background: There are little differences between biosimilars and reference products. Therefore, these products must be compared to the reference medicinal products in terms of safety and efficiency. Aims: This open label study has been done to compare adverse drug reaction and clinical efficiency of Rosastim and Neupogen in order to show the same efficiency and safety in the gastric cancer through two parallel groups.

Study Design: Our research is a randomized open-label parallel design clinical study.

Methods: 5 μg/kg subcutaneously G-CSF therapy were randomly injected to eligible consenting subjects (60 patients) the day after chemotherapy for five days. Allpatients were followed up every three weeks. neutrophil and lymphocyte counts and adverse drug reactions (bone pain, nausea, fever, allergy, liver enzyme increasing)were measured in those patients according to a protocol.

Results: Neutrophil and lymphocyte counts did not have significant differences in two groups (P-value > 0.05). Furthermore, according to homogeneity chi-square test, frequency of adverse drug reactions in two groups in all cycles did not have significant differences (P-value > 0.05).

Conclusion: Our study suggested that Rosastim is as same as Neupogen in case of effectiveness and tolerance when used as an adjuvant in patients with gastric cancer. Therefore, this biosimilar is a suitable and an alternative option for patients need G-CSF.