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Australian guidelines for biosimilars Posted 10/06/2011

Last update: 5 January 2018

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.

TGA administers the Therapeutic Goods Act 1989. This legislation provides a framework for a risk management approach that allows the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality.

TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.

In Australia, the European Union (EU) guidelines were adopted in August 2008 [1]. And on 30 July 2013, the TGA published its own guidance on the evaluation of biosimilars:

Evaluation of biosimilars
Effective date: 1 July 2013
http://www.tga.gov.au/industry/pm-argpm-biosimilars-00.htm

In addition, Australia has adopted the following guidelines from the EU on similar biological medicinal products.

1. Overarching guidelines
These guidelines cover all biosimilar products:

Guideline on similar biological medicinal products CHMP/437/04 Rev 1
TGA Effective date: 22 May 2015
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues EMEA/CHMP/BMWP/42832/2005 Rev1
Under public consultation, effective date: 1 July 2015
TGA Effective date: 22 May 2015
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf

2. Specific guidelines
These guidelines are specific to the type of biosimilar product:

Recombinant erythropoietins EMEA/CHMP/BMWP/94526/2005 Corr.
Effective date: 29 September 2006
www.tga.gov.au/pdf/euguide/bmwp9452605en.pdf

Revision of 2008. EMEA/CHMP/BMWP/301636/2008 not yet adopted by TGA.
Effective date: 1 October 2010
www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2010/04/WC500089474.pdf

Recombinant G-CSF EMEA/CHMP/BMWP/31329/200
Effective date: 29 September 2006
www.tga.gov.au/pdf/euguide/bmwp3132905en.pdf

Recombinant human insulin EMEA/CHMP/BMWP/32775/200
Effective date: 12 September 2006
www.tga.gov.au/pdf/euguide/emea3277505en.pdf

Low molecular weight heparins EMEA/CHMP/BMWP/118264/2007
Effective date: 5 August 2009
www.tga.gov.au/pdf/euguide/bmwp11826407en.pdf

Somatropin EMEA/CHMP/BMWP/94528/2005
Effective date: 29 September 2006
www.tga.gov.au/pdf/euguide/bmwp9452805en.pdf

Recombinant interferon alpha EMEA/CHMP/BMWP/102046/2006
Effective date: 17 December 2010
www.tga.gov.au/pdf/euguide/chmp10204606enfin.pdf

3. Specific guidelines – not yet adopted
TGA has the following guidelines published for information only for specific biosimilar products. These guidelines have not yet been adopted by the TGA.

Monoclonal antibodies EMEA/CHMP/BMWP/403543/2010
Under public consultation, effective date: 1 December 2012
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf

4. Other guidelines
Other guidelines relevant for biosimilars from the EMA include:

Immunogenicity assessment of biotechnology-derived therapeutic proteins
EMEA/CHMP/BMWP/14327/2006
Effective date: 22 June 2009
www.tga.gov.au/pdf/euguide/bmwp1432706en.pdf

Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process - Non-Clinical and Clinical Issues
CHMP/BMWP/101695/06
Effective date: 8 April 2009
www.tga.gov.au/pdf/euguide/bmwp10169506en.pdf

5. Other guidelines – not yet adopted
TGA has the following guidelines published for information only. These guidelines have not yet been adopted by the TGA.

Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use EMEA/CHMP/114720/2009
Under public consultation, effective date: 15 July 2009
End of consultation: 28 May 2014
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128688.pdf

Related articles
Biosimilars approved in Australia

EU guidelines for biosimilars

Global biosimilars guideline development – EGA’s perspective

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Global biosimilars guideline development – EGA’s perspective [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Guidelines/Global-biosimilars-guideline-development-EGA-s-perspective 

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Source: TGA

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