Biosimilars approved in Australia

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

Last update: 26 February 2021

In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.

Biologicals 1 V13D05

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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