Australia to adopt EMA’s monoclonal antibody guideline

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The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 14 February 2014 that it was carrying out public consultations on the adoption of European Union guidelines in Australia.

TGA V13H23

The documents under question include guidelines on bacterial agents, fungal agents and insulin products, and also include the European Medicines Agency’s (EMA’s) guideline on clinical and non-clinical aspects of biosimilar monoclonal antibodies.

The monoclonal antibody guideline was finalized on 15 June 2012 and came into effect in Europe on 1 December 2012, along with another guideline on immunogenicity assessment of monoclonal antibodies [1].

Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues
Effective date: 1 December 2012

The guideline highlights the importance of the demonstration of the comparability of a biosimilar monoclonal antibody with the monoclonal antibody in the original, authorized medicine. However, it also notes that ‘deviations from disease-specific guidelines … may be warranted’. The guideline also allows for extrapolation of indications for biosimilar monoclonal antibodies.

TGA is asking for comments on the proposed adoption or non-adoption of the EU guidelines, and in particularly as to whether stakeholders support the proposed adoption of the guidelines.

Feedback on the guidelines can be submitted to TGA until the end of 28 March 2014 via post or email (

TGAhas already adopted many of EMA’s guidelines for biosimilars, as well as publishing its own guidance on the evaluation of biosimilars [2].

Related articles

EMA publishes draft guideline for biosimilar human insulin

EU guidelines for biosimilars


1.   GaBI Online - Generics and Biosimilars Initiative. EMA finalises biosimilar monoclonal antibody guidelines []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 21]. Available from:

2.   GaBI Online - Generics and Biosimilars Initiative. Australian guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 21]. Available from:

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Source: TGA

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