Australian guide to biosimilars

Biosimilars/General | Posted 04/05/2015 post-comment0 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.

Guidance V13F21

‘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].

Related articles
Australia should not copy New Zealand’s drug pricing system

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 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.

Source: GMiA

comment icon Comments (0)
Post your comment
Related content
Promotion of biosimilar product development in Puerto Rico
Biological 143606710 V14J14ct
Biosimilars/General Posted 17/10/2023
CVS’ Cordavis to launch Sandoz’s Hyrimoz (adalimumab)
15 AA010699
Biosimilars/General Posted 03/10/2023
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010