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Biosimilars approved in Australia Posted 21/02/2014

Last update: 22 November 2019

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 20 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)
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
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
Data updated 22 November 2019 *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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