On April 21st, ASBM presented to the World Health Organization’s (WHO’s) 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fourteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online for the first time.
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 69th INN Consultation – held on October 22, 2019 and in which ASBM also participated – may be viewed here. From the Executive Summary:
ASBM was of the opinion that the delay in implementing the biologic qualifier (BQ) was a result of opposition to it and reasoned that arguments for delay were baseless and nullified. It also contended that during this delay period, WHO was pressuring smaller regulators and proponents to drop support for the BQ despite the ASBM having addressed the main objections raised by opponents.
A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively. The ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number. According to the FDA, there should be adequate mechanisms in place to differentiate adverse events arising from reference or biosimilar products.
In a Canadian survey of 2017, only 20% of physicians recorded the non-proprietary name in patient records and only 1% of those identified the medicine using the Drug Identification Number. The ASBM also queried whether the INN Expert Group’s recommendation to WHO had changed, highlighting that neither the WHO Constitution nor Bylaws require unanimous consent of all stakeholders. It felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now. Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.
ASBM felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.
Read more about ASBM’s work on the issue of biologic naming here.
Read the full Executive Summary of the 69th INN Consultation here.