Waller, C.F., Semiglazov, V.F., Tjulandin, S., Bentsion, D., Chan, S., & Challand, R. (2010). A phase III randomized equivalence study of biosimilar filgrastim versus Amgen filgrastim in patients receiving myelosuppressive chemotherapy for breast cancer. Onkologie, 33, 504–511.
The purpose of the study was to demonstrate bioequivalence of two different filgrastim products.
Patients were randomized to receive one of the two types of filgrastim at the same dose and schedule. Treatment was 5 mcg subcutaneously daily on day 2 of chemotherapy in each cycle, and continued until absolute neutrophil count (ANC) was greater than 3 x 109/L or treatment had been given for 14 days.
37 European outpatient centers in various countries
Mutliple phases of care
Randomized, double-blind phase III
Incidence of severe neutropenia was 77.6% in one group and 68.2% in the other, with no statistically significant difference. Duration of severe neutropenia across groups in cycle 1 ranged from 1.3 –1.6 days on average, and was lower in both groups in subsequent cycles. There were no differences in outcomes between the two. Those receiving Hospira filgrastim had a slightly higher incidence of bone pain than Amgen filgrastim; however, overall prevalence of skeletal pain was similar in both groups.
The results of this study showed that these two different preparations of filgrastim are bioevquivalent.
This study was designed purely to demonstrate bioequivalence of these two filgrastim products.