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European Group Criticizes Proposed WHO, FDA Biosimilar Naming Schemes
BioPharma-Reporter.com (04/13/2015) Brennan, Zachary
The European Biosimilars Group (EBG), part of the European Generic Medicines Association, says that more complex systems for naming biosimilars raises the risk of physicians and pharmacists omitting information and disrupting the tracking of adverse events. The World Health Organization has proposed the biological qualifier (BQ) system, under which biosimilars would be tagged with a random alphabetic code that represents a biological active substance manufactured at a specific site. Adoption of this system would complement the use of International Nonproprietary Names (INNs). EBG proposes that an additional identifier for biosimilars is unnecessary, as there are many other identifiers available, such as trade name, INN plus company name, and the national drug codes. A proposal to connect the BQ to the active substance manufacturing site is also a problem, according to EBG, as it disconnects "the product from the company legally responsible for its safety--the market authorization holder," and is redundant, because the lot number already provides information such as distribution and storage. The Food and Drug Administration has not yet released guidance on biosimilar naming, but it has approved one biosimilar: Sandoz's Zarxio (filgrastims-ndz).
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