On March 19th, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 78th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland on October 18th, 2023. ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. The proceedings of the INN Consultation are bound by confidentiality pending the publication of the Executive Summary by the WHO. However, the recently-released Executive Summary from the 77th INN Consulation (held October 19, 2023) lays out the benefits for a distinct nomenclature standard, and highlights the ongoing support for such a standard, both from ASBM as well as from regulators. From the Executive Summary: 

The ASBM has supported the INN Group’s Biological Qualifier (BQ) scheme since its inception in 2012, and since then has doggedly presented data on the importance of a BQ to enhancing patient safety and pharmacovigilance (PV). However, they have also learned that WHO moves slowly, has many global health issues to deal with and has many stakeholders. Almost 10 years after the inception of the BQ, with no further action ensuing, a WHO report in 2021 highlighted that a lack of consistency in naming biosimilars had caused concern in prescribing, prescription mix-ups, unintended switching and traceability, and concluded that naming and labelling was important for product identification, PV and prescribing. When the BQ was first proposed, ASBM noted that several global regulatory agencies supported the scheme, including the US FDA which eventually adopted its own not dissimilar system comprising a random four-letter suffix. Other supporting agencies await the WHO implementing a global system. In the EU, the EMA has stated that it does not need a BQ as it has an alternative system in place but recognises the value of a unified system. Several arguments have been raised by stakeholders opposed to a BQ; however, in each case these have proven to be unfounded. For example, it had been stated that distinguishable names may imply inferior products, but this has not been the case in USA. In addition, surveys have shown that a supposed lack of support by physicians and global regulators was incorrect.  Over these years also, the ASBM has surveyed and met with many global regulators and physicians and the vast majority support distinct nomenclature. The lack of action with the BQ has forced many regulators, either assigning the same non-proprietary name to biosimilars or in some cases to adopt their own system. However, most of them are willing to support a WHO system if it is implemented. The ASBM made a proposal to quantify support for the BQ. . It acknowledged support for a BQ system and with the debate having continued for 10 years now it strongly encourage the WHO to take a leadership role.  Dr Balocco noted that the department had a new ADG and that WHO was soon to have a new Director-General. The WHO has been asked to work on a Global Substance Identifier (GSID) and there may be an opportunity to bring in the BQ as part of this. The INN Programme is in fact ready to implement a BQ. Dr Balocco expressed hope that a decision would be taken soon as the INN by itself is not sufficient for PV.   

Read the full Executive Summary of the 77th INN Consultation here.