Investigation of Nonproprietary Name Suffix Use for Biologics and Biosimilars

    Basic Details
    Date Posted
    Wednesday, April 24, 2019
    Status
    In progress
    Medical Product
    biologic
    biosimilar
    Description

    The goal of this project is to understand the role of FDA’s nonproprietary name suffix in routine clinical care. Currently, there are several ways used by different federal agencies to identify biologics and biosimilars. This project will evaluate how one large institution identifies biosimilars in their systems, from the point of physician order entry through insurance coding and reimbursement.

    Workgroup Leader(s)

    Joshua Baker, MD, MSCE; University of Pennsylvania School of Medicine, Philadelphia, PA

    Sarah Dutcher, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

    Lubna Merchant, MS, PharmD; Office of Medication Error Prevention and Risk Management, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

    Workgroup Member(s)

    Charles Leonard, PharmD, MSCE; Vincent Lo Re, MD, MSCE; Judy Shea, PhD; University of Pennsylvania School of Medicine, Philadelphia, PA

    Susan Forrow, BA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA