Biosimilars are given a nonproprietary name (INN) that consists of a core name and a suffix that is devoid of meaning and composed of four lowercase letters. For example, infliximab-dyyb and infliximab-abda are biosimilars of infliximab. The suffix naming convention is intended to facilitate pharmacovigilance, which is the monitoring of the safety and effectiveness of drugs after they are approved and marketed.

The regulation of biosimilars in Latin America varies by country, but some of the largest markets, such as Argentina, Brazil and Mexico, have approved several biosimilars. However, not all countries have adopted the suffix naming convention for biosimilars.

According to an editorial by two regulatory experts (1), suffixes for biosimilars can support adverse event reporting and build provider and patient confidence in biosimilars. They argue that suffixes can help trace adverse events to the correct product and avoid negative perceptions of biosimilars or an entire product class. However, some stakeholders oppose the suffix naming convention and argue that it is unnecessary, confusing and potentially harmful to biosimilar uptake. They claim that current naming conventions are sufficient for pharmacovigilance and that suffixes may imply that biosimilars are not as safe or effective as originator biologics.

(1) Editorial: Biosimilar Suffixes Are Important for Pharmacovigilance, Uptake. https://www.centerforbiosimilars.com/view/editorial-biosimilar-suffixes-are-important-for-pharmacovigilance-uptake.