No Difference in Risk of Febrile Neutropenia Between Patients Receiving Pegfilgrastim Biosimilar vs Originator

Results from a Real-World Cohort Study 

According to findings from a real-world cohort study recently published in the Journal of Managed Care + Specialty Pharmacy, there was no difference in risk of febrile neutropenia (FN), a severe side effect of chemotherapy, observed between patients who received biosimilar pegfilgrastim (pegfilgrastim-jmdb and pegfilgrastim-cbqv) vs originator pegfilgrastim. 

According to Ching-Yu Wang, MS, University of Florida, Florida, “Pegfilgrastim is a preventative treatment for febrile neutropenia, and new biosimilar options may provide lower costs compared with the original treatment (originator).” 

To test if biosimilar pegfilgrastim is a viable treatment option for FN, the study authors aimed to compare the risk of FN among patients who received originator pegfilgrastim vs biosimilar pegfilgrastim. The primary endpoint was the duration of severe neutropenia in cycle 1, while the risk assessment in subsequent cycles was the secondary endpoint. 

Patients with cancer, including breast, lung, colorectal, esophageal and gastric, pancreatic, prostate, ovarian, and non-Hodgkin lymphomas, initiating myelosuppressive chemotherapy courses were selected. 2,045 patients with various types of cancer (including breast, lung, colorectal, esophageal and gastric, pancreatic, prostate, ovarian, and non-Hodgkin lymphomas) who were initiating myelosuppressive chemotherapy and who were given either originator pegfilgrastim or biosimilar pegfilgrastim within 3 days of chemotherapy completion were enrolled in this study. 

Of these patients, 47.1% (n=964) used pegfilgrastim originator, and 52.9% used biosimilar pegfilgrastim (n=1081). Patients who used biosimilar pegfilgrastim were made up of 445 patients who used pegfilgrastim-jmdb and 636 patients who used pegfilgrastim-cbqv. Propensity score matching was performed in a 1 to 1 ratio and equivalence hypothesis tests were utilized to compare FN-related risks in cycle 1, and then across all cycles, between the 2 groups. 

After matching, 13 out of 445 patients who used originator pegfilgrastim and 17 out of 445 patients who used pegfilgrastim-jmdb developed FN after cycle 1 of chemotherapy, making the risk difference 0.9%. After matching, 14 out of 633 patients who used originator pegfilgrastim and 16 out of 633 patients who used pegfilgrastim-cbqv developed FN, with a risk difference of 0.32%. The results of subsequent cycles were consistent with those of cycle 1. 

As risk results were comparable across all groups, it can be concluded that there was no difference in FN risk between patients who received originator pegfilgrastim vs biosimilar pegfilgrastim. The study authors stated that these results “support wider adoption of pegfilgrastim biosimilars among payers, providers, and patients.” 

Source: 

Wang CY, Vouri SM, Park H, Heldermon CD, Brown JD. Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study. J Manag Care Spec Pharm. 2023;29(2):119-127. doi:https://doi.org/10.18553/jmcp.2023.29.2.119