Australian guide to biosimilars

Generics and biosimilars Initiative

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Australian guide to biosimilars

Biosimilares/General | Posted 04/05/2015 0 Post your comment

Australia’s Generic Medicines Industry Association (GMiA) has launched a Guide to Biosimilars. The guide is designed to provide a concise, ‘user-friendly’ reference on the subject for patients, clinicians, pharmacists, politicians and policymakers.

‘Around the world, biosimilars are now able to offer alternative treatment options to many expensive biological medicines, with the potential for considerable cost savings’, said GMiA CEO, Ms Belinda Wood. The GMiA Guide will help explain ‘the important role of biosimilars in improving patient access to new treatments while managing PBS (Australia’s Pharmaceutical Benefits Scheme [1]) costs’.

GMiA represents companies that manufacture, supply and export generics. Earlier this year, the association called on the country’s Minister for Industry to convene a Medicine Manufacturing Taskforce [2]. GMiA warned that recent pricing reforms had cut medicine prices to unsustainable levels that could cause irreversible damage to the Australian generics industry.

According to the Consumers Health Forum of Australia, a body which represents healthcare consumers, Australians have been paying over the odds for their generics for some time [3].

National guidelines for biosimilars were published by Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), in 2013 [4]. In January 2015, TGA followed the example of recent international developments, particularly from the World Health Organization [5]; by changing the way biosimilars are named in the country [6].

Naming requirements in Australian biosimilars guidance

References
1.   GaBI Online - Generics and Biosimilars Initiative. Australian price cuts make PBS affordable [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Policies-Legislation/Australian-price-cuts-make-PBS-affordable
2.   GaBI Online - Generics and Biosimilars Initiative. Generics taskforce for Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Generics/General/Generics-taskforce-for-Australia
3.   GaBI Online - Generics and Biosimilars Initiative. Australians pay too much for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Generics/General/Australians-pay-too-much-for-generics
4.   GaBI Online - Generics and Biosimilars Initiative. Australian guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Guidelines/Australian-guidelines-for-biosimilars
5.   GaBI Online - Generics and Biosimilars Initiative. WHO investigates use of a biological qualifier for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Biosimilars/General/WHO-investigates-use-of-a-biological-qualifier-for-biosimilars
6.   GaBI Online - Generics and Biosimilars Initiative. Australia reviewing plans for naming biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Guidelines/Australia-reviewing-plans-for-naming-biosimilars

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Source: GMiA