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Biosimilars approved in Australia Posted 21/02/2014

Last update: 13 January 2017

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 13 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, insulin, erythropoietin, follicle stimulating hormone (FSH) 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

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

Grandicrit

epoetin lambda

Anaemia
Cancer
Chronic kidney failure

27 Jan 2010

Sandoz

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

SciTropin A

somatropin

Growth disturbance due to chronic renal insufficiency
Pituitary dwarfism
Turner syndrome

29 Sep 2010

SciGen Australia

Tevagrastim#

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

29 Aug 2011

Aspen Pharmacare Australia

Zarzio#

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

7 May 2013

Sandoz

*Data collected on 13 January 2017, updated on 7 October 2016
**Date listed on Australian Register of Therapeutic Goods (ARTG) 
#Listed on Australian Pharmaceutical Benefits Scheme (PBS)

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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