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Zarxio (Filgrastim-sndz) & Signal Identification

Basic Details
Status
Complete
Last Updated
Thursday, June 1, 2023
Original Posting Date
Health Outcome(s)
signal identification
Purpose
Methods, Characterization, or Development
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

FDA initiated this pilot study in Sentinel to explore the use of TreeScanTM for routine drug safety surveillance of biosimilars, using a use case of Zarxio (Filgrastim-sndz). Biosimilars are biologic medications that are highly similar to existing approved biologics with no identified clinically meaningful differences in safety, effectiveness, and quality. However, the complex nature of biologics generally means a biosimilar is not identical to the reference product. TreeScan is a signal identification approach that scans thousands of health outcomes simultaneously while adjusting for multiple scenarios that can be used to monitor the underlying assumption of no clinical differences.

The study specifically sought to monitor non-pregnancy and non-cancer outcomes among new users of Zarxio compared to new users of Neupogen. FDA determined the statistical alerts generated by the TreeScan analysis do not warrant further evaluation or action. This pilot demonstrated that tree-based scan statistics can be applied to the Sentinel Distributed Database to simultaneously evaluate thousands of safety outcomes for biosimilar medicines as an additional surveillance tool.

Analytic Code Link(s) (2)
Outcome Monitoring Following Zarxio Use: A Signal Identification Analysis Outcome Monitoring Following Zarxio Use: An Updated Signal Identification Analysis
Result(s) (3)
Utilization of Select Biological Products: A Descriptive Analysis Outcome Monitoring Following Zarxio Use: A Signal Identification Analysis Outcome Monitoring Following Zarxio Use: An Updated Signal Identification Analysis