On March 28th, ASBM participated in the World Health Organization’s 76th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the twentieth INN Consultation in which ASBM has participated.
ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
The proceedings at the Consultation are bound by confidentiality pending the WHO’s publication of the Executive Summary. ASBM will share the Executive Summary when it is published in the coming months.
The recently-published Executive Summary from the 75th INN Consultation, at which ASBM presented in October 2022, summarizes ASBM’s position regarding the value of distinct biologic nomenclature:
One significant challenge to efficient global cooperation is the lack of harmonization. Significantly for the INN group, a 2020 WHO report identified inconsistent nomenclature as a remaining challenge as it is clear that naming and labelling are both very important for pharmacovigilance and prescribing. Indeed, surveys show that there remains a clear need for harmonization of distinguishable names with only two-thirds of ADR reports recording the brand name of the biologic, and even fewer recording the non-proprietary name. Other surveys show that only a small proportion of physicians record the non-proprietary name and extremely few use an officially recommended drug code number.
In conclusion, the ASBM urged the WHO to make a voluntary distinct naming standard available to facilitate international cooperation and harmonization. This will help speed approval, increasing access to biosimilars while promoting safety and building confidence through strong post-market monitoring.
Read the WHO’s summary of the 75th INN Consultation here.