On May 1st, ASBM Executive Director, Michael Reilly, Esq. and Advisory Board Chair, Philip Schneider, MS, FASHP; presented before the 66th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the tenth INN Consultation at which ASBM has presented since 2013.
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 for the 65th INN Consultation may be viewed here.
The day prior to the meeting, ASBM met with Asst. Director-General Mariângela Simão; Head of Regulation of Medicines and other Health Technologies Emer Cooke, and INN Programme Manager Rafaella Balocco, to discuss the status of the BQ proposal. In July 2014, the INN Expert Group put forward the BQ recommendation for a distinguishable naming approach, however to date, this policy has yet to be implemented. Should the WHO advance the BQ proposal, it would give other nations around the world a model that they may choose to adopt, thereby creating a world standard.
ASBM surveys have shown strong support for distinct naming among physicians worldwide. Sixty-six 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.
In addition, the April 11 meeting on Harmonization of Biologic Nomenclature sponsored by ASBM revealed strong stakeholder support both for distinct naming and for international harmonization of naming systems; participants agreed that WHO involvement was necessary to advance these aims. The meeting included representatives from FDA, Health Canada, physician societies, pharmacists, and patient advocacy organizations.