2017 Volume 7 Issue 1 Pages 3-15
Compared to conventional drugs, biomedicines are generally more clinically beneficial, but are relatively expensive and their use may contribute to increase in health care costs. In Japan, despite expectation of widespread use of biosimilars, the switch from original biomedicines to biosimilars has been slower than that from low-molecular-weight drugs to their generics. This could be because physicians and pharmacists are not fully aware that the efficacy and safety of an original biomedicine and its biosimilar are equivalent. We, therefore, examined the bioequivalency of original granulocyte-colony stimulating factor (G-CSF) biomedicines (G-CSF originators hereafter) and G-CSF biosimilars by comparing the efficacy and safety of the G-CSF originator, Gran® Syringe (Kyowa Hakko Kirin Co. Ltd., Japan), with a biosimilar, Filgrastim BS Injection Syringe “F” (Filgrastim BS hereafter, Fuji Pharma Co. Ltd., Japan), by using data collected over 3 years, starting in April 2012, at Mishuku Hospital. The economic effect of switching to Filgrastim BS was also examined. We compared both G-CSF preparations in terms of time-dependent change in leukocyte counts, incidence of febrile neutropenia, and abnormal laboratory values. Because the time to start the administration of G-CSF differed between the originator-treated and the Filgrastim BS-treated groups due to the revision of the Clinical Practice Guidelines for Cancer, and leukocyte count instead of neutrophil count was used as the parameter, their efficacy could not be simply compared. However, the results suggest that Filgrastim BS is equivalent to its originator in terms of efficacy and safety in this study. Further, the cost-saving effect of switching to Filgrastim BS accounted for 10% of the entire cost saved by switching to generics and biosimilars in 2014. Thus, we demonstrated that switching from G-CSF originators to Filgrastim BS was beneficial for maintaining clinical efficacy and safety and reducing costs for Mishuku Hospital.
