Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has decided to keep the same names for biologicals.
In its specific guidance for biosimilars [1], the TGA requires that the name of a biosimilar in Australia be made up of:
- the reference product Australian Biological Name (ABN), thus identifying the reference product with which the biosimilar has demonstrable comparability, and
- a biosimilar identifier, consisting of: the prefix sim(a)- and a three-letter code issued by the World Health Organization (WHO) International Nonproprietary Name (INN) Committee, according to its draft policy.
Then, in July 2017 the agency launched a public consultation into the naming of biologicals in order to gather feedback on proposals for potential biological naming systems [2]. The agency proposed four options for the public to comment on:
1. No change to the current system.
2. Keep the current system, but with activities that increase public reporting of adverse events with the inclusion of the product’s trade name, AUST R and batch number.
3. Move towards adopting a bar-code system similar to the EU.
4. Introduce the use of suffixes to the naming of biologicals – in a similar way to the system implemented in the US.
After looking at the results of the public consultation [3], the agency has decided to continue using the Australian biological name (without a specific identifier suffix) and to strengthen the adverse event reporting. This includes making the product’s trade name, as well as the non-proprietary name, a mandatory field when reporting an adverse event to the TGA.
The International Generic and Biosimilar Medicines Association (IGBA) congratulated the Australian Government in making this decision. The association said that the government’s decision ‘aligns with the EU, which has approved the highest number of biosimilar medicines worldwide, and has acquired considerable experience of their use and safety’. They added that ‘over the last 10 years, the EU monitoring system for safety concerns has not identified any difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicine. Furthermore, the preliminary results of an ongoing European Medicines Agency’s (EMA) pharmacovigilance study showed that 95.5% overall product identification has been achieved for classes of biologicals for which biosimilar medicines have been approved.’
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References
1. GaBI Online - Generics and Biosimilars Initiative. Naming requirements in Australian biosimilars guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Guidelines/Naming-requirements-in-Australian-biosimilars-guidance
2. GaBI Online - Generics and Biosimilars Initiative. Australia’s TGA consults on naming of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/General/Australia-s-TGA-consults-on-naming-of-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Comments on TGA’s modified approach to naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Policies-Legislation/Comments-on-TGA-s-modified-approach-to-naming-biologicals
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