Following WHO Proposal, Australia Suspends Biosimilar Naming Plan

Sunday, February 1, 2015

Source: FDA News

Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named.

The Therapeutic Goods Administration announced its decision to revert back to old biosimilar naming standards last week. For the time being, biosimilars in Australia will simply use their Australian biologic name. A Neupogen (filgrastim) biosimilar, for example, would be identified as “'TRADENAME' filgrastim,” the agency says.

The TGA had been moving forward with a 2013 naming plan that combined the ABN with a WHO international nonproprietary name, or INN, convention that assigned each biosimilar name a three-letter qualifier unique to the product and manufacturer.

However, last July, WHO updated its naming convention to a four-letter biological qualifier with which manufacturers could voluntarily comply. The updated convention superseded the one the TGA had been complying with, the agency says, forcing it to halt implementation of the plan while it reviews the new policy.

View All News »