Biosimilars approved in Australia

Biosimilares/General | Posted 21/02/2014 post-comment0 Post your comment

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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Source: PBS, TGA

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