Last update: 6 May 2025
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 65 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.
The latest biosimilars approved in early 2025 include the ustekinumab biosimilar Uteknix [3]; denosumab biosimilars Stoboclo and Osenvelt; the natalizumab biosimilar Tyruko; and the aflibercept biosimilar Eydenzel [4].
| Table 1: TGA approved biosimilars*
|
| Product name
|
Active substance
|
Therapeutic area
|
Authorization date**
|
Manufacturer/ Company name
|
| Abevmy
|
bevacizumab
|
Metastatic colorectal cancer
|
6 Sep 2021
|
Alphapharm
|
| Abrilada
|
adalimumab
|
Ankylosing spondylitis
Crohn’s Disease
Enthesitis-related arthritis
Hidradenitis suppurativa
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
|
22 Feb 2021
|
Pfizer
|
| 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 / 9 Nov 2017 (ARTG list date)
|
Amgen
|
| Basaglar
|
insulin glargine
|
Diabetes
|
21 Nov 2014
|
Eli Lilly Australia
|
| Bemfola
|
follitropin alfa
|
Infertility treatment
|
27 Nov 2015
|
Finox Biotech/ Gedeon Richter - Also registered under the brand name Afolia
|
| Bevaciptin
|
bevacizumab
|
Metastatic colorectal cancer
|
2 Nov 2021
|
Cipla - Also registered under the brand name Bevacip
|
| Brenzys
|
etanercept
|
Ankylosing spondylitis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
|
22 Jul 2016
|
Samsung Bioepis
|
| Byooviz
|
ranibizumab
|
Degenerative myopia
Diabetic retinopathy
Macular edema
Wet macular degeneration
|
24 Aug 2022
|
Samsung Bioepis
|
| Ciptunec
|
adalimumab
|
Ankylosing spondylitis
Crohn’s Disease
Enthesitis-related arthritis
Hidradenitis suppurativa
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
|
6 Sep 2022
|
Cipla - Also registered under the brand name Ardalicip
|
| Enoxapo
|
enoxaparin
|
Venous thromboembolism
|
10 Feb 2020
|
Apotex
|
| Erelzi
|
etanercept
|
Ankylosing spondylitis
Juvenile idiopathic arthritis
Paediatric psoriasis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
|
30 Nov 2017
|
Sandoz
|
| Etera
|
etanercept
|
Ankylosing spondylitis
Juvenile idiopathic arthritis
Paediatric psoriasis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
|
1 Oct 2020
|
Alphapharm - Also registered under the brand name Rymti
|
| Exarane
|
enoxaparin
|
Venous thromboembolism
|
28 Jul 2023
|
Juno
|
| Exarane Forte
|
enoxaparin
|
Venous thromboembolism
|
28 Jul 2023
|
Juno
|
| Eydenzelt
|
aflibercept
|
Age-related neovascular (wet) macular degeneration (nAMD)
Diabetic macular oedema
Myopic choroidal neovascularisation
Visual impairment due to macular oedema secondary to retinal vein occlusion
|
31 Mar 2025
|
Celltrion
|
| Filpelga
|
pegfilgrastim
|
Neutropenia
|
19 Aug 2022
|
Cipla
|
| Fulphila
|
pegfilgrastim
|
Neutropenia
|
17 Aug 2018
|
Alphapharm
|
| 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 / Also registered under the brand names Simabtra, Hertuzu
|
| Hulio
|
adalimumab
|
Ankylosing spondylitis
Crohn’s Disease
Enthesitis-related arthritis
Hidradenitis suppurativa
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
|
22 Feb 2021
|
Alphapharm
|
| Hyrimoz
|
adalimumab
|
Ankylosing spondylitis
Crohn’s Disease
Enthesitis-related arthritis
Hidradenitis suppurativa
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
|
1 Mar 2019
|
Sandoz
|
| Inflectra#
|
infliximab
|
Ankylosing spondylitis Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
19 Aug 2015
|
Pfizer - Also registered under the brand names Remsima, Emisima, Flixceli
|
| Kanjinti
|
trastuzumab
|
Early breast cancer
|
16 May 2019
|
Amgen
|
| Lapelga
|
pegfilgrastim
|
Neutropenia
|
19 Aug 2019
|
Apotex
|
| Mvasi
|
bevacizumab
|
Metastatic colorectal cancer
|
30 Jun 2020
|
Amgen
|
| Neutropeg
|
pegfilgrastim
|
Neutropenia
|
19 Aug 2019
|
Accord Healthcare
|
| 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
|
| Odacio
|
adalimumab
|
Ankylosing spondylitis
Crohn’s Disease
Enthesitis-related arthritis
Hidradenitis suppurativa
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
|
17 Jun 2020
|
Fresenius Kabi
|
| Ogivri
|
trastuzumab
|
Early breast cancer
|
11 Dec 2018
|
Alphapharm
|
| Omnitrope#
|
somatropin
|
Growth disturbance due to chronic renal insufficiency
Pituitary dwarfism
Turner syndrome
|
29 Sep 2010
|
Sandoz
|
| Onbevzi
|
bevacizumab
|
Metastatic colorectal cancer
|
24 Jan 2024
|
Samsung Bioepis
|
| Ontruzant
|
trastuzumab
|
Early breast cancer
|
9 Jan 2019
|
Samsung Bioepis
|
| Osenvel
|
denosumab
|
Giant cell tumours
Skeletal-related events in patients with bone metastases
|
4 Apr 2025
|
Celltrion
|
| Ovaleap
|
denosumab
|
Giant cell tumours
Skeletal-related events in patients with bone metastases
|
10 Mar 2021
|
Theramex
|
| Pelgraz
|
pegfilgrastim
|
Neutropenia
|
13 Dec 2019
|
Accord Healthcare
|
| Renflexis
|
infliximab
|
Ankylosing spondylitis
Crohn's disease
Rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Ulcerative colitis
|
28 Nov 2016
|
Samsung Bioepis
|
| Raniviz
|
ranibizumab
|
Degenerative myopia
Diabetic retinopathy
Macular edema
Wet macular degeneration
|
20 Dec 2023
|
Actor
|
| Ritosa
|
teriparatide
|
Infertility treatment
|
2 May 2024
|
Sun Pharma
|
| Riximyo
|
rituximab
|
B-cell NHL
Chronic lymphocytic leukaemia
Microscopic polyangiitis Rheumatoid arthritis
Wegener’s granulomatosis
|
30 Nov 2017
|
Sandoz Australia
|
| Ruxience
|
rituximab
|
B-cell NHL
Chronic lymphocytic leukaemia
Microscopic polyangiitis Rheumatoid arthritis
Wegener’s granulomatosis
|
3 Mar 2021
|
Pfizer
|
| 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 (Alphapharm)
|
| Stoboclo
|
denosumab
|
Postmenopausal osteoporosis
|
4 Apr 2025
|
Celltrion
|
| Teriparatide GH
|
teriparatide
|
Infertility treatment
|
5 Apr 2023
|
Generic Health
|
| Teriparatide LAPL
|
teriparatide
|
Infertility treatment
|
5 Apr 2023
|
Generic Health
|
| Teriparatide LUPIN
|
teriparatide
|
Infertility treatment
|
5 Apr 2023
|
Generic Health
|
| Teriparatide RBX
|
teriparatide
|
Infertility treatment
|
2 May 2024
|
Sun Pharma
|
| Teriparatide SUN
|
teriparatide
|
Infertility treatment
|
2 May 2024
|
Sun Pharma
|
| Terrosa
|
teriparatide
|
Infertility treatment
|
1 Dec 2020
|
Gedeon Richter
|
| Tevagrastim#
|
filgrastim
|
Cancer
Haematopoietic stem cell transplantation
Neutropenia
|
29 Aug 2011
|
Aspen Pharmacare Australia
|
| Trastucip
|
trastuzumab
|
Early breast cancer
|
18 Jul 2022
|
Pfizer - Also registered under the brand name Tuzucip
|
| Trazimera
|
trastuzumab
|
Early breast cancer
|
19 Aug 2019
|
Pfizer
|
| Truvelog/Solostar
|
insulin aspart
|
diabetes mellitus
|
15 Oct 2020
|
Sanofi-Aventis
|
| Truxima
|
rituximab
|
B-cell NHL
Chronic lymphocytic leukaemia
Microscopic polyangiitis Rheumatoid arthritis
Wegener’s granulomatosis
|
16 Apr 2018
|
Celltrion
|
| Tyruko
|
natalizumab
|
Multiple sclerosis
|
4 Apr 2025
|
Sandoz
|
| Uteknix
|
ustekinumab
|
Plaque psoriasis
Psoriatic arthritis
|
11 Feb 2025
|
Alvotech/Cipla
|
| Vegzelma
|
bevacizumab
|
Metastatic colorectal cancer
|
5 Sep 2023
|
Celltrion
|
| Wezlana
|
ustekinumab
|
Crohn’s disease
Plaque psoriasis, including paediatric plaque psoriasis
Psoriatic arthritis
|
22 Jan 2024
|
Amgen
|
| Yuflyma
|
adalimumab
|
Ankylosing spondylitis
Crohn’s Disease
Enthesitis-related arthritis
Hidradenitis suppurativa
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
|
25 Feb 2022
|
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 6 May 2025.
**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
3. GaBI Online - Generics and Biosimilars Initiative. Australia approves ustekinumab biosimilar Uteknix [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 2]. Available from: www.gabionline.net/biosimilars/news/australia-approves-ustekinumab-biosimilar-uteknix
4. GaBI Online - Generics and Biosimilars Initiative. Australia biosimilar approvals in early 2025 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 2]. Available from: www.gabionline.net/biosimilars/news/australia-biosimilar-approvals-in-early-2025
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