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Evaluation of biosimilars
Naming conventions for 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 This proposal has superseded the previous INN position on which the TGA policy was based.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.
Australian Biological Names (ABN)
Under the Therapeutic Goods Regulations (1990) Schedules 12 & 13, all medicines are required to use Australian Approved Names (AAN) in both:
- Product Information (PI)
- Consumer Medicine Information (CMI).
In the case of a biosimilar, this will be drawn from the Biologicals List or Australian Biological Names (ABN).
Therapeutic Goods Order No. 69 General requirements for labels for medicines (2001) Section 3(10) mandates the use of the AAN/ABN for all active ingredients and excipients on labels.
A biosimilar is not identical to its reference product and must be assumed to be different to any other biosimilar as no direct comparability study has been conducted. As small differences between biosimilars can give rise to differences in clinical behaviour, in particular in immunogenic effects, certain additional nomenclature provisions are necessary to ensure that it is possible to distinguish between biosimilars and clearly identify the reference product.
The TGA therefore requires that the ABN for a biosimilar be composed of:
- the reference product ABN, thus identifying the reference product with which the biosimilar has demonstrable comparability
- a biosimilar identifier, consisting of: the prefix sim(a)- and a three letter code issued by the WHO International Non-proprietary Name (INN) Committee, according to its draft policy.
The object of this naming policy is to allow prescribers to identify the reference product and to distinguish clearly between biosimilars.
These distinctions are also important for pharmacovigilance purposes.
Nomenclature example
The fictitious company IgPharm registers a biosimilar for the monoclonal antibody infliximab.
The product uses the ABN infliximab simfam. This is used in full in all labelling and in each reference to the product in the PI and CMI.
Although the biosimilar ABN will be partly based on the approved ABN used by the reference product, sponsors will need to apply:
- to the WHO INN Committee for a biosimilar three letter code
- to the ABN Committee for the use of the INN three letter code in the biosimilar identifier
- for this identifier to then be added to the list of Australian Approved Names.
Note
An application for the use of a specific biosimilar identifier may be rejected if:
- it does not comply with WHO INN naming policy
- it could otherwise be confused with an existing non-proprietary name or trademark.
Status of the biosimilar identifier
Addition of a biosimilar identifier to the AAN list by the ABN Committee does not in any way imply endorsement or acceptance by the TGA of the substance as a biosimilar, but only that the sponsor's application for the use of a biosimilar identifier has been approved.
The assessment of biosimilarity or comparability is made by evaluators on the basis of a complete dataset, not by the ABN Committee.
If the TGA determines that the substance is not biosimilar:
- do not use the ABN of the reference product
- do not use the biosimilar identifier
- apply for a new and unique ABN.
Tradenames
Biosimilars are required to have a clearly distinguishable tradename from all other products, especially the reference product and other biosimilars.
Basing the tradename on "the active ingredient name with the company identified" as indicated in Best practice guideline on prescription medicine labelling is not appropriate for biosimilars. This is because it may:
- give the impression that the biosimilar is a generic medicine
- lead to confusion in both prescribing and dispensing. (As noted by Dr Annemarie Hellebek in the EMA Medication errors workshop report (28 Feb-1Mar 2013) EMA/144458/2013 (pdf,219kb), "generic product names using common stems may... cause name confusion".)
- contribute to difficulties in traceability following adverse event reporting
- be considered an unacceptable presentation under section 25(1)e of the Act, as it has the potential to mislead.
For these reasons the use of the active ingredient ABN in the tradename of a biosimilar is not acceptable.