Naming conventions for biosimilars in Australia

Following recent international developments in the area of biosimilar naming, Australian regulator the Therapeutic Goods Administration (TGA) said today that it will not be continuing with the previously proposed naming convention for biosimilars while a review of the policy is undertaken.

In July 2013, the TGA published guidance on biosimilar naming based upon the combination of a WHO Program on International Nonproprietary Names (INN) issued biosimilar identifier with the Australian biological name (ABN). In July 2014, the WHO-INN published a draft policy “Biological Qualifier - An INN Proposal.” This proposal has superseded the previous INN position on which the TGA policy was based. This means the TGA biosimilar naming convention described below cannot be implemented and the TGA is undertaking a review of the policy.

In the interim biosimilars will use the Australian biological name without a specific biosimilar identifier suffix, for example a biosimilar to the reference product Neupogen filgrastim would be named “TRADENAME” filgrastim.