Biosimilars in Australia – a-flagging and sustainability

Biosimilars/General | Posted 08/01/2021 post-comment0 Post your comment

Australia first introduced guidelines for biosimilars back in August 2008 when it adopted a number of guidelines from the EU on similar biological medicinal products [1].

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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 to view the following manuscript published in GaBI Journal:

Biosimilars naming and prescribing policy in Australia

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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


To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latin América.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

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

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Source: Australian DoH, GBMA, PBS

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