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Evaluation of biosimilars
Naming conventions for biosimilars
21 January 2015
Following recent international developments in the area of biosimilar naming the TGA will not be continuing with the previously proposed naming convention for biosimilars while a review of the policy is undertaken.
In July 2013 the TGA published guidance on biosimilar naming based upon the combination of a WHO Programme on International Nonproprietary Names (INN) issued biosimilar identifier with the Australian biological name (ABN). In July 2014 the WHO - INN published a draft policy 'Biological Qualifier - An INN Proposal'. This proposal has superseded the previous INN position on which the TGA policy was based. This means the TGA biosimilar naming convention described below cannot be implemented and the TGA is undertaking a review of the policy.
In the interim biosimilars will use the Australian biological name without a specific biosimilar identifier suffix, for example a biosimilar to the reference product Neupogen filgrastim would be named 'TRADENAME' filgrastim.
'Evaluation of biosimilars' is an initial guideline on the regulation of biosimilar products. As the TGA's understanding of these products is still evolving, this document will be updated from time to time. If you would like to provide feedback to the TGA on this document please contact firstname.lastname@example.org.
The purpose of the guidance is to:
- Assist sponsors to identify the data necessary to support applications for the registration of biosimilars
- Clarify the scientific and regulatory principles used by the TGA to evaluate those applications.
This guidance refers solely to the evaluation of biosimilars.
Most biosimilars are likely to contain biotechnology-derived proteins as the active substance(s), but this guidance also applies to other biosimilars such as those consisting of:
- vaccines and monoclonal antibodies
- polysaccharides, such as low molecular weight heparins.
- What is a biosimilar?
- The legislative provisions for the evaluation of biosimilars
- The evaluation of biosimilars
- Reference products for biosimilars
- In-house primary reference standard for biosimilars
- Extrapolation of indications
- Post registration regulation of biosimilars
- Pharmacovigilance of biosimilars
- Naming conventions for biosimilars
- Labels, product information (PI) and consumer medicine information (CMI) for biosimilars
- Appendix 1 - Suggested techniques for inclusion in comparability studies
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Office of Medicines Authorisation||1/07/2013|