On October 22nd, ASBM presented at the World Health Organization’s (WHO’s) 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the thirteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary from the 68th INN Consultation – held on April 2, 2019 and in which ASBM also participated – may be viewed here.
Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June. In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.