A memo published by the FDA’s Center for Drug Evaluation and Research describing a review of the nonproprietary name for Cablivi (caplacizumab-yhdp) evaluates the four-letter suffix for inclusion in the nonproprietary name for caplacizumab. This suffix was generated by the FDA based on principles described in the guidance document highlighted in the following paragraph and was deemed to be non-similar to the names of other currently marketed products, devoid of meaning, lacking any abbreviations that could be misinterpreted, and avoiding any misrepresentations with respect to safety or efficacy of this product. [1]

Per FDA guidance, biological products licensed under the Public Health Service Act (PHS Act) are to bear a nonproprietary name that includes an FDA-designated suffix. Under this naming convention, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. This naming convention will facilitate pharmacovigilance for originator biological products, related biological products, and biosimilar products containing related drug substances when other means to track a specific dispensed product are not readily accessible or available. Full details from the FDA regarding the nonproprietary naming of biological products may be accessed at the following link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-guidance-industry. [2]