Naming conventions for biosimilars by TGA

January 23, 2015 9:02 AM

Australia’s drug watchdog, the Therapeutic Goods Administration (TGA) has announced that, it will not update the way in which in names biosimilar products.

Following recent international developments in the area of biosimilar naming the TGA 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 Programme 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 This proposal has superseded the previous INN position on which the TGA policy was based.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 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.


Source: TGA

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