Table 3.

Comparative overview for naming biosimilars between the regulatory guidelines of EMA, WHO, US FDA, BGTD, PMDA, and TGA.

Regulatory Guideline	Naming
EMA	Commercial name, appearance, and packaging should differ; INN * should be the same for related biosimilars
WHO	Changes are being considered to the current policy of using INN
US FDA	Draft guidance proposes that all biologics be given a four-letter suffix to the INN
BGTD	Not specified
PMDA	Non-proprietary name of the reference product followed by “BS” and an abbreviation to reference the manufacturer
TGA	Australian biologic name without a specific biosimilar identifier suffix (policy is under review)

* INN: see A16.