Following WHO Proposal, Australia Suspends Biosimilar Naming Plan

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 The updated convention superseded the one the TGA had been complying with, the agency says, forcing it to halt implementation of the plan while it reviews the new policy.

Biosimilars naming has been a hot button topic among brand and biosimilars manufacturers. Guidance on the FDA’s view of biosimilars naming is expected sometime this year.  

GPhA and some manufacturers have argued that biosimilars need no name qualifiers and should be treated as same-name generic therapies because, in the U.S. at least, they gained marketing authorization by showing that they have no clinically meaningful differences from the reference product. Biosimilars already have all the information on their labels necessary to track adverse events without a unique qualifier, GPhA says.   

The TGA and others counter that biosimilars are not exact copies of the reference therapy. Small differences between biosimilars can lead to different clinical behaviors, especially in immunogenic effects, the agency says in justifying name qualifiers. — Bryan Koenig