FDA proposes suffix for biosimilar product names

August 31, 2015 by Chain Drug Review Academy of Managed Care Pharmacy, AMCP, Bertrand Liang, biologic drugs, biologic products, Biologics Prescribers Collaborative, biosimilar product names, biosimilars, Biosimilars Forum, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Edith Rosato, Food and Drug Administration, GPhA, Janet Woodcock, Karen Midthun, The Biosimilars Council Featured Articles, Leading Headlines, Pharmacy, Supplier News

WASHINGTON — Early feedback on the Food and Drug Administration’s proposal on naming conventions for biosimilars shows a mixed response. Late late week, the FDA published draft guidance recommending that reference biologic products and biosimilars have nonproprietary names that share a core drug substance name and an FDA-designated suffix unique for each product. For interchangeable