On October 19th, ASBM participated in the World Health Organization’s 73rd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the seventeenth INN Consultation in which ASBM has participated.
ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
While the discussions at the INN Consultation are confidential pending publication of an Executive Summary by the INN Programme, the Executive Summary from the 72nd INN Consultation – held April 13th, 2021 and in which ASBM also participated – may be viewed here. From that report:
“Many published reports, including ASBM’s own surveys of prescribers over several years, show a clear lack of identification of the brand name in ADR reports, especially in the EU in which brand name reporting became a mandatory requirement in 2012.”
“ASBM highlighted that reporting on brand names in ADR reports continues to be inadequate despite widespread recognition of its importance. WHO has identified a lack of a naming standard as a regulatory challenge that undermines the strong pharmacovigilance needed for biologics and biosimilars, and ASBM underlined that the WHO has the ability and the duty to make a global standard available to address this global pharmacovigilance need.”
Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, including holding a series of meetings with FDA, Health Canada, and the WHO on the subject.
