The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA). TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products, including biosimilars.

Once licensed by TGA, there is a system of cost subsidy for drugs, called the Pharmaceutical Benefits Scheme (PBS), whose role is to balance cost and the contribution of an individual drug to an improved outcome for patients. Drugs are generally not widely prescribed in Australia before they are listed on the PBS.

In August 2008, Australia adopted a number of guidelines from the EU on similar biological medicinal products [1].

Aczicrit and Grandicrit (epoetin lambda) were the first products approved in Australia as biosimilars in 2010. To date, TGA has approved eight biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor and erythropoietin, for use in Australia, see Table 1.

Table 1: TGA approved biosimilars*

*Data collected on 12 November 2013, updated on 7 February 2014; **Date listed on Australian Register of Therapeutic Goods (ARTG); ^#Listed on Australian Pharmaceutical Benefits Scheme (PBS).