The Alliance for Safe Biologic Medicines has called for the adoption of a unique U.S. Adopted Name (USAN) for biologic and biosimilar therapeutics as “a foundational element of the safety framework” for the biosimilar approval pathway that the Food and Drug Administration (FDA) is required to establish under the Affordable Care Act.
In his November 28, 2012, article published in the Food and Drug Law Institute’s (FDLI’s) biweekly Food and Drug Policy Forum, Alliance Chair Richard Dolinar claims that patient safety and the need for traceability require USANs for biosimilars. He suggests that the “non-proprietary name of a reference product and product[s] biosimilar to it should have a common, shared root but have distinct and differentiating suffixes” and that “[p]roducts designated interchangeable should have a distinct name from the reference product for which they are considered interchangeable to facilitate accurate attribution of adverse events.”
Dolinar explains how biologic identification using National Drug Codes, as called for by some stakeholders, would not be practical and explores the European experience with biosimilar naming, which has apparently resulted in difficulties tracing biologics when adverse events occur. He also recommends that the United States Pharmacopeia (USP) “work with FDA to adapt the product monograph system to accommodate the unique attributes of structurally related but distinct biologic medicines.” The Alliance is apparently concerned that USP has indicated in its FDA submissions “that the issuance of a monograph should dictate the nomenclature for a biologic medicine.” Dolinar opines that the monograph system could be adapted “to accommodate prefixes or suffixes while still permitting the enforcement of common standards.”