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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 27 Jan 2010 Sandoz Amgevita adalimumab
Ankylosing spondylitis 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 22 Jul 2016 Samsung Bioepis Erelzi etanercept
Ankylosing spondylitis 30 Nov 2017 Novartis Grandicrit epoetin lambda
Anaemia 27 Jan 2010 Sandoz Hadlima adalimumab Rheumatoid arthritis## 24 Jan 2018 Samsung Bioepis Herzuma trastuzumab
Early breast cancer 17 Jul 2018 Celltrion Healthcare Inflectra# infliximab
Ankylosing spondylitis Crohn’s disease 19 Aug 2015 Hospira (Pharmbio) Nivestim# filgrastim
Cancer 16 Sep 2010 Hospira Novicrit# epoetin lambda
Anaemia 27 Jan 2010 Novartis Pharmaceuticals Australia Omnitrope# somatropin
Growth disturbance due to chronic renal insufficiency 29 Sep 2010 Sandoz Renflexis infliximab
Ankylosing spondylitis 28 Nov 2016 Samsung Bioepis Riximyo rituximab
B-cell NHL 30 Nov 2017 Sandoz Australia SciTropin A somatropin
Growth disturbance due to chronic renal insufficiency 29 Sep 2010 SciGen Australia Semglee insulin glargine Diabetes 28 March 2018 Biocon/Mylan Tevagrastim# filgrastim
Cancer 29 Aug 2011 Aspen Pharmacare Australia Truxima rituximab
B-cell NHL 16 Apr 2018 Celltrion Zarzio# filgrastim
Cancer 7 May 2013 Sandoz
*Data updated 22 November 2019
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Cancer
Chronic kidney failure
Crohn’s Disease
Enthesitis-related arthritis
Hidradenitis suppurativa
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Juvenile idiopathic arthritis
Paediatric psoriasis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Cancer
Chronic kidney failure
Metastatic breast cancer
Metastatic gastric cancer
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Haematopoietic stem cell transplantation
Neutropenia
Cancer
Chronic kidney failure
Pituitary dwarfism
Turner syndrome
Crohn's disease
Rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Ulcerative colitis
Chronic lymphocytic leukaemia
Microscopic polyangiitis Rheumatoid arthritis
Wegener’s granulomatosis
Pituitary dwarfism
Turner syndrome
Haematopoietic stem cell transplantation
Neutropenia
Chronic lymphocytic leukaemia
Microscopic polyangiitis Rheumatoid arthritis
Wegener’s granulomatosis
Haematopoietic stem cell transplantation
Neutropenia
**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.
Australia issues new biosimilars guidance
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
Source: PBS, TGA
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