On October 17th, ASBM Chair, Madeline Feldman, M.D., FACR; Advisory Board Chair, Philip Schneider, MS, FASHP; and Executive Director, Michael Reilly, Esq. appeared before the 65th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland.

 

ASBM has regularly appeared before the INN Consultation since 2013 and continues to advocate for distinguishable naming of biologics — more recently in support of the adoption of a Biological Qualifier (BQ) proposal as a solution on naming. The BQ proposal is a random, non-memorable 4-letter consonant only suffix that would be assigned to all biological active substances.

 

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 advance of the trip to Geneva, ASBM submitted a letter to the Director General
of the WHO, Dr. Tedros Adhanom Ghebreyesus, advocating for the swift implementation 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.

ASBM’s letter stated:

 

 “The BQ has the potential to become at an important adjunct to global pharmacovigilance systems for all biologic medicines and it should be implemented before further proliferation of national naming schemes occurs. This is especially important for those countries who have less developed pharmacovigilance systems, and who may not have appropriate naming policies in place for biologics and biosimilars.”

 

Read full letter here.