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Zarxio (Filgrastim-sndz) & Signal Identification

    Basic Details
    Last Updated
    Thursday, June 1, 2023
    Original Posting Date
    Methods and Development
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    FDA initiated this pilot study in Sentinel to explore the use of TreeScanTM for biosimilars safety assessments. 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 determine whether Zarxio (filgrastim-sndz), a biosimilar, has a different safety signal profile relative to Neupogen (filgrastim), the reference biologic product. Although the TreeScan analysis generated four alerts, FDA determined the alerts do not warrant further evaluation or action. This pilot study suggested that tree-based scan statistics can simultaneously evaluate thousands of safety outcomes to provide additional assurance beyond routine surveillance that biosimilar and reference products, indeed, have no clinically significant differences in safety.