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How antibody USAN and INN sing a different tune

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We recently reported about the new World Health Organization (WHO) naming scheme for antibody therapeutics which resulted in deleting the source infix in international nonproprietary names (INN) (Parren, Carter & Plückthun, MAbs 2017 9:898-906). The changes implemented remove critical ambiguities in antibody naming going forward.

The WHO has now released the full executive summary of the 64th Consultation on International Nonproprietary Names for Pharmaceutical Substances at which the decision to remove the source infix was taken. The summary is in full agreement with the information previously provided in our perspective.  Notably, the new scheme will change the sounds of antibody names that have become so familiar to us (see Table 1). This diversification is in fact quite important as distinct names are thought to further reduce the potential for medication errors as more therapeutic antibodies make it to the market.

Alignment of INNs with United States Adopted Names (USAN) is essential since (approved) antibody therapeutics will usually carry both an INN and a USAN. We are therefore very pleased to report that the USAN Council has agreed to implement the same naming scheme. Eliminating the source infix also ends an important disagreement between the USAN Council and WHO on how the source infix should be defined and assigned (also see Parren et al. Mabs 2017 for more information). Importantly, it is noted that no changes to previously assigned USAN names are contemplated. Similarly, WHO notes that substituting previously assigned INNs requires extraordinary circumstances such as medication, prescription or distribution errors that occur due to name similarities, also indicating that existing INN will unlikely be changed.

Notably, the WHO stresses the importance of careful dissemination of information on the new scheme and highlights the role of The Antibody Society. Consequently we will continue to update you via this channel as new information becomes available.

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The source infix is out!

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The World Health Organization (WHO) issues International Nonproprietary Names (INN) for therapeutic antibodies. These INNs contain the suffix –mab preceded by a source (or species) infix such as -xi- for chimeric, -zu- for humanized and -u- for human antibodies. Changes in definitions and procedures, which WHO implemented in 2014, resulted in INN with inconsistent source designations for an array of chimeric and humanized antibodies. Discussions spearheaded by The Antibody Society have now led to a resolution of the issue. At the 64th Consultation on INN held in April 2017, the WHO INN expert group decided to eliminate the source infix. Although the change was officially announced today, WHO implemented the changes promptly and applicants have already received INN issued under the new naming scheme, i.e., without an INN source infix. The Antibody Society board members Paul W.H.I. Parren, Paul J. Carter and Andreas Plückthun provide analysis and more information in a Perspective article that will be published in the upcoming August/September 2017 issue of mAbs. Society members will be alerted by email when this article is available for downloading from the ‘Latest Articles’ section of the mAbs website.

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WHO’s Open Session on INN to be held on April 12, 2016

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The World Health Organization (WHO) recently introduced new definitions for the assignment of antibody international nonproprietary names (INN). Linear protein sequence is now used to define humanness, which is a substantial change in the method by which therapeutic antibodies were previously classified as chimeric, humanized or human. The new definitions are scientifically flawed, provide results that are inconsistent with names of many existing antibody therapeutics, and do not consider advances in antibody technology and antibody development experience.

The Antibody Society will represent the Antibody Community at large at the WHO’s Open Session at the 62nd consultation on INN for pharmaceutical substances in Geneva on April 12, 2016, and we will request modifications that address the problems with the new system.
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The Antibody Society’s presentation at the WHO’s Open Session on April 12, 2016 is available to Society members. Please log in to access the presentation, located on the Presentations page in the Members Only section.

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