The purpose of the guidance, according to the TGA, is to both assist sponsors in identifying the data necessary to support applications for the registration of biosimilars, as well as to clarify the scientific and regulatory principles used by the TGA to evaluate those applications.

The guidance, while acting as an overarching guidance for biosimilars containing biotechnology-derived proteins as the active substance(s), also applies to more complex biosimilars, such as vaccines and monoclonal antibodies, as well as to polysaccharides, such as low molecular weight heparins.

The guidance is available on the TGA website:

Evaluation of biosimilars
Effective date: 30 July 2013
http://www.tga.gov.au/industry/pm-argpm-biosimilars-00.htm

It addresses comparability studies for evaluating biosimilars, covering physicochemical properties, biological activity, content, purity and impurity profile, glycosylation and immunogenicity, post-registration regulation and pharmacovigilance, biosimilar naming conventions and labelling and product information.

The guidance comes in addition to EMA’s guidance on biosimilars, which the TGA adopted back in 2008 and should not create any major changes in the way biosimilars are developed and registered in Australia.

Although Australia was quick to follow the EU, putting in place a biosimilars pathway in 2008, there are still relatively few biosimilars licensed in the country. This is perhaps explained, however, by the country’s relatively small population of only 23 million [1].

Related articles

Australian guidelines for biosimilars

EU guidelines for biosimilars

Reference
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.2013.0203.030

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