Australia to Revise its Biosimilar Naming Conventions

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Following a proposal by the World Health Organization, Australia will abandon a previously proposed update in biosimilar nomenclature.

Australia’s Therapeutic Goods Administration (TGA) announced plans to revise its proposed biosimilar naming conventions following a July 2014 draft policy from the World Health Organization (WHO). WHO said in the draft policy that biological qualifiers will now consist of four letters, and will be applied prospectively and retrospectively to all biological products given international non-proprietary names (INNs).

Australia’s original plan was to refer to biosimilars by their Australian Biological Name (ABN) followed by the prefix “sim(a),” where “(a)” was the three-letter code for the biosimilar assigned by WHO’s INN panel, reports Regulatory Affairs Professional Society (RAPS). Following WHO’s four-letter biological qualifier convention announcement, TGA will review its naming 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,” TGA said on its website.

Different naming conventions have emerged in various countries for biosimilars released in the market. Some areas exclusively use a product’s INN, while others use the INN and a distinct nonproprietary identifier. “This variety of nomenclature approaches means that, at present, the same biological medicine can have different identifiers in different parts of the world,” WHO wrote in its proposal. Without the proper consensus on naming, WHO argued, confusion related to prescribing and dispensing could result. According to WHO, achieving consensus on the naming of biosimilars will facilitate decision-making processes on substitution and interchangeability.