Last update: 26 February 2021
In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.
Last update: 26 February 2021
In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.
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 [1].
In August 2008, Australia adopted a number of guidelines from the EU on similar biological medicinal products [2].
Aczicrit and Grandicrit (epoetin lambda) were the first products approved in Australia as biosimilars in 2010. To date, TGA has approved 26 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, insulin, erythropoietin, follicle stimulating hormone (FSH), monoclonal antibody and tumour necrosis factor (TNF)-inhibitor, for use in Australia, see Table 1.
Table 1: TGA approved biosimilars* | ||||
Product name | Active substance | Therapeutic area | Authorization date** | Manufacturer/ Company name |
Aczicrit | epoetin lambda |
Anaemia Cancer Chronic kidney failure |
27 Jan 2010 | Sandoz |
Amgevita | adalimumab |
Ankylosing spondylitis Crohn’s Disease Enthesitis-related arthritis Hidradenitis suppurativa Polyarticular juvenile idiopathic arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis Uveitis |
18 Oct 2017 | Amgen |
Basaglar | insulin glargine | Diabetes | 21 Nov 2014 | Eli Lilly Australia |
Bemfola | follitropin alfa | Infertility treatment | 27 Nov 2015 | Finox Biotech |
Brenzys | etanercept |
Ankylosing spondylitis Psoriatic arthritis Psoriasis Rheumatoid arthritis |
22 Jul 2016 | Samsung Bioepis |
Erelzi | etanercept |
Ankylosing spondylitis Juvenile idiopathic arthritis Paediatric psoriasis Psoriatic arthritis Psoriasis Rheumatoid arthritis |
30 Nov 2017 | Novartis |
Grandicrit | epoetin lambda |
Anaemia Cancer Chronic kidney failure |
27 Jan 2010 | Sandoz |
Hadlima | adalimumab | Rheumatoid arthritis## | 24 Jan 2018 | Samsung Bioepis |
Herzuma | trastuzumab |
Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
17 Jul 2018 | Celltrion Healthcare |
Inflectra# | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
19 Aug 2015 | Hospira (Pharmbio) |
Lapelga | pegfilgrastim | Neutropenia | 19 Aug 2019 | Apotex |
Neutropeg | pegfilgrastim | Neutropenia | 19 Aug 2019 | Apotex |
Nivestim# | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
16 Sep 2010 | Hospira |
Novicrit# | epoetin lambda |
Anaemia Cancer Chronic kidney failure |
27 Jan 2010 | Novartis Pharmaceuticals Australia |
Omnitrope# | somatropin |
Growth disturbance due to chronic renal insufficiency Pituitary dwarfism Turner syndrome |
29 Sep 2010 | Sandoz |
Renflexis | infliximab |
Ankylosing spondylitis Crohn's disease Rheumatoid arthritis Psoriasis Psoriatic arthritis Ulcerative colitis |
28 Nov 2016 | Samsung Bioepis |
Riximyo | rituximab |
B-cell NHL Chronic lymphocytic leukaemia Microscopic polyangiitis Rheumatoid arthritis Wegener’s granulomatosis |
30 Nov 2017 | Sandoz Australia |
SciTropin A | somatropin |
Growth disturbance due to chronic renal insufficiency Pituitary dwarfism Turner syndrome |
29 Sep 2010 | SciGen Australia |
Semglee | insulin glargine | Diabetes | 28 March 2018 | Biocon/Mylan |
Tevagrastim# | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
29 Aug 2011 | Aspen Pharmacare Australia |
Trazimera | trastuzumab | Early breast cancer | 19 Aug 2019 | Pfizer |
Truvelog | insulin aspart | diabetes mellitus | 23 Oct 2020 | Sanofi-Aventis |
Truxima | rituximab |
B-cell NHL Chronic lymphocytic leukaemia Microscopic polyangiitis Rheumatoid arthritis Wegener’s granulomatosis |
16 Apr 2018 | Celltrion |
Zarzio# | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
7 May 2013 | Sandoz |
Ziextenzo | pegfilgrastim | Neutropenia | 6 Sep 2019 | Sandoz |
Zirabev | bevacizumab | Metastatic colorectal cancer | 21 Nov 2019 | Pfizer |
*Data updated 26 February 2021. **Date listed on Australian Register of Therapeutic Goods (ARTG); #Listed in the Australian Pharmaceutical Benefits Scheme (PBS); ##In Australia, decisions about indication extrapolation for biosimilars are made by the TGA. Rheumatoid arthritis is the only TGA-approved indication for Hadlima, as the sponsor has not sought to have Hadlima TGA-registered for the remaining Humira-approved indications at this time. NHL: non-Hodgkin’s lymphoma. |
Related article
Australia issues new biosimilars guidance
References
1. Power DA. Licensing and prescribing biosimilars in Australia. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(3):152-4. doi:10.5639/gabij.2014.0304.043
2. GaBI Online - Generics and Biosimilars Initiative. Australian guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 21]. Available from: www.gabionline.net/Guidelines/Australian-guidelines-for-biosimilars
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Source: PBS, TGA
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