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79th Consultation on International Nonproprietary Names for Pharmaceutical Substances: Summary

The 79th Consultation on International Nonproprietary Names for Pharmaceutical Substances (INN) took place from 22-25 October 2024 in Geneva, addressing key topics in global health, medicine access, and pharmaceutical nomenclature. The consultation emphasized INN's role in standardizing drug naming to improve rational use, reduce costs, and ensure equitable access worldwide. Here is a concise summary of the proceedings.

Executive Summary and Welcome

• Opening remarks by Director Sarel Malan highlighted INN's importance beyond mere naming, stressing its impact on global healthcare through cost reduction and rational drug use. Achievements included publishing a Lancet letter on cell-based therapies and advancing INN data analysis. Future work includes reviewing 249 new INN requests, particularly for COVID-19 variants, advanced therapies, and chemical substances.
• Dr. Raffaella Balocco, Head of the INN Programme, thanked participants and mentioned ongoing collaborative efforts, such as the School of INN (SoINN), to expand INN's educational reach.

Election of Leadership

• Professor Sarel Malan was elected Chair, with Dr. Akinola Adisa as Co-chair for biologicals, Dr. Adi Mester as Co-chair for chemicals, and Dr. James Robertson as Rapporteur.
• The Notes of the 78th INN Consultation were adopted without objection.

Nomenclature Discussions

• Open Database of Proteins (ODP): The final ODP software was launched for use in the INN database (IDMIS), enabling faster comparison of protein requests. This tool aids in defining monoclonal antibodies (mAbs) with a generic model, using codes for mandatory data, and has been praised by regulatory evaluators.
• Monoclonal Antibodies (mAbs): Work focused on new stems for mAb subtypes, such as -bart, -ment, -mig, and -degs for degraders, reflecting advances in cancer therapy. Challenges included naming complex structures like tri-specific proteins and managing potential confusion.
• Bifunctional Proteolysis-Targeting Substances (BPTS): After discussions, the suffix "-deg" was approved for degraders, with infixes based on targets (e.g., "-bru-deg" for Bruton's kinase). Current names will not be changed to avoid disruption.
• Capsids and Virus-Like Particles (VLPs): New stems "-vilp" were proposed for VLPs to avoid confusion with the "-cap" suffix for capsids. The ODP may be integrated with WHO brand data, but only its core database is maintained.
• Cell Therapy and mRNA: Cell therapy naming was streamlined to shorten INN lengths, and mRNA infixes were evaluated to distinguish therapeutic categories, approving "-momeran" for vaccines and "-te-" for therapeutic proteins.
• General INN Criteria: 281 requests were reviewed, leading to 263 new names, with 155 for biologicals. Four stems and ten suffixes were updated, and definitions require unique chemical or structural data for consistency.

School of INN (SoINN) Updates

• The 22nd steering committee meeting reviewed SoINN's progress, including the "Stems in a Pill" educational program now available in Spanish, French, and English. SoINN's website sees high traffic, prompting plans to improve exposure through collaborations like Wikipedia.
• Pilot sites from universities worldwide shared teaching achievements, with candidate sites expanding INN's reach through translation and pharmacovigilance research.

Collaborators’ Updates

• PMDA, Japan: Harmonized standards with USP and Ph.Eur. for active ingredients; launched joint programs.
• TGA, Australia: Implemented regulations for vaping products under the Vaping Reforms Act 2024, allowing only INN-compliant products.
• UMC, Sweden: Collaborating on IDMP identifiers; plans to tag substance names with INN status.
• USAN, USA: Reviewed 33 drug substances, approved new stems, and notes 252 USAN adoptions in 2024.
• USP, USA: Updated analytical standards, added pharmaceutical impurities, and supports nitrosamine testing through guidelines.
• WCO, Switzerland: Examined HS classification for INN, focusing on stems like "-golix" and planned modifications to Explanatory Notes for antibiotics.
• Oslo Centre: Working on ATC and DDD codes for new substances, with a small SoINN course in preparation.
• WIPO, Geneva: INN names are integrated into WIPO's global brand database for trademark assessments, highlighting policy similarities in name avoidance conflicts.

Stakeholder Open Session Highlights

• Aflofarm and SciencePharma advocated for changing cytisinicline to cytisine, offering consistency, patient familiarity, and reduced confusion. Balocco noted the complexity, citing WHO policies and member state agreements.
• Rivus Pharmaceuticals proposed "controlled metabolic accelerators" to address obesity, seeking harmonized nomenclature for mitochondrial-activating drugs like HU6.
• Nurix Therapeutics supported a new INN suffix "-brudeg" for degraders, challenging current stem conventions.
• Alliance for Safe Biologic Medicines (ASBM) called for preserving clinical data in biosimilar naming, opposing dimissed INN Biological Qualifier (BQ), and highlighted growing cost savings from biosimilars.

This consultation reinforced INN's role in global health, with ongoing efforts to standardize naming, enhance collaboration, and address emerging therapeutic areas. The next INN Consultation is scheduled for March 2025.