TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Evaluation of biosimilars

Book pagination

30 July 2013

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 This proposal has superseded the previous INN position on which the TGA policy was based.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.

Introduction

'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 info@tga.gov.au.

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.

Contents

Version history

Version Description of change Author Effective date
V1.0 Original publication Office of Medicines Authorisation 1/07/2013

Book pagination