This was then followed, in 2010, by the approval of Aczicrit and Grandicrit (epoetin lambda) by the country’s drug regulator, the Therapeutic Goods Administration (TGA). To date, the TGA has approved 27 biosimilars within the product classes of human growth hormone (HGH), granulocyte colony-stimulating factor (G-CSF), insulin, erythropoietin (EPO), follicle stimulating hormone (FSH), monoclonal antibody and tumour necrosis factor (TNF)-inhibitor, for use in Australia [2].

From the 27 approved biosimilars, currently, 18 biosimilar brands, representing nine biologicals, are subsidized on the Pharmaceutical Benefits System (PBS) to treat conditions including cancer, rheumatoid arthritis and inflammatory bowel diseases.

The PBS began as a limited scheme in 1948, with free medicines for pensioners and a list of 139 ‘life-saving and disease preventing’ medicines free of charge for others in the community. Today the PBS provides timely, reliable and affordable access to necessary medicines for Australians. The PBS is part of the Australian Government’s broader National Medicines Policy. Under the PBS, the government subsidizes the cost of medicine for most medical conditions.

In order to ensure the sustainability of the scheme, price cuts have been introduced for many of the medicines supplied through the PBS [3]. In addition to this, the PBS has also introduced a-flagging for biosimilars, which are available at a reduced price compared to the originator biological. In fact, a statutory price reduction of up to 25% applies to all brands of a medicine after its first generic/biosimilar brand is PBS listed.

Medicines deemed substitutable at the pharmacy level by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) include a notation in the official PBS known as an ‘a’ flag. The decision gives pharmacists the authority to substitute the medicine for its reference product.

To date, eight biosimilars approved in Australia have been a-flagged. A-flagging biosimilars on a case-by-case basis, as well as other policies and incentives, including clearer guidelines on interchangeability and substitutability designations, expert medical consensus statements on biosimilar use and pricing incentives, are expected to increase confidence in biosimilars. This, in turn, is expected to improve the slow market uptake of biosimilars in Australia, which has generally been attributed to the understandable lack of familiarity and comfort with biosimilars by physicians, pharmacists and patients [4].

Increased use of biosimilar medicines is expected to increase market competition, improve the government’s capacity to fund expanded access to biologicals as they become more affordable, and reduce the risk of medicine shortages.

Editor’s comment
Readers interested to learn more about prescribing policies in Australia are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Biosimilars naming and prescribing policy in Australia

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GaBI Journal Citation Impact
1.7 – Citescore 2019 (calculated on 6 May 2020)
2.0 – CiteScoreTracker 2020 (Last updated on 7 December 2020)

Related article
Australia’s PBAC recommends substitution of biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. Australian guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Guidelines/Australian-guidelines-for-biosimilars 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia 
3. GaBI Online - Generics and Biosimilars Initiative. Australian price cuts make PBS affordable [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Policies-Legislation/Australian-price-cuts-make-PBS-affordable 
4. GaBI Online - Generics and Biosimilars Initiative. Switching from biologicals to biosimilars in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Switching-from-biologicals-to-biosimilars-in-Australia 

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