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Investigating Potential Differences in the Safety Profiles of Biosimilars Relative to Originator Products Using a Tree-Based Scan Statistic

    Basic Details

    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.

    This presentation compares the safety profile of Zarxio (filgrastim-sndz) to that of its originator. It was presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management.


    Mallika L. Mundkur, José J. Hernández-Muñoz, Monica A. Muñoz, Qin Ryan, Rosanna Setse, Sarah Dutcher, Meredith Epperson, Laura Hou, James Marshall, Elizabeth K. Siranosian, Emma C. Whited, Michael D. Blum, Judith C. Maro