Australian Regulator Hits Restart on Plan to Name Biosimilars

Regulatory NewsRegulatory News | 21 January 2015 |  By 

Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has announced it will no longer implement a planned update to the way in which it names biosimilar products following a proposal by the World Health Organization to change a naming standard on which Australia relied for its policy.


Under TGA's original proposal, biosimilars would have been referred to using their Australian Biological Name (ABN) followed by the prefix “sim(a),” where “(a)” is the three-letter code for the biosimilar assigned by WHO's INN committee.

However, in an update published to its website on 20 January 2015, TGA said the policy, which relied in part on the WHO's Programme on International Nonproprietary Names (INN), will not be implemented following a proposed update to INN last July.

WHO's new draft policy, Biological Qualifier – An INN Proposal, revised the previously proposed naming convention for biosimilars. The draft policy now states that a biological qualifier will be applied “prospectively and retrospectively” to all biological substances given INNs. The biological qualifier will now consist of four letters.

In light of the change to INN, TGA will be conducting a review of its policy before determining how to proceed. In the meantime, TGA provided an interim policy for identifying biosimilars:

“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 ‘TRADENAME’ filgrastim.”

What’s in a Name?

WHO cautions that without international consensus on a naming convention for biosimilars, a situation could emerge where the same biosimilar product could be given different non-proprietary names in different jurisdictions. WHO gives the example:

“An epoetin that is registered in Europe (European Medicines Agency/EMA) using the INN epoetin alfa was subsequently registered by Australia (Therapeutic Goods Administration/TGA) with the non- official but INN-like non-proprietary name epoetin lambda.”

The proposed solution in the draft proposal would be to use names such as “epoetin alfa bbbb.” WHO argues the adoption of their biological qualifier system would prevent the “proliferation of separate and distinct national qualifier systems.”

Importance for Prescribers

Biosimilars are typically defined in terms of their comparability to a reference product in terms of safety, quality and efficacy. By their nature, biosimilar products are not 100% equivalent to their reference products. This means that it is important for regulators and healthcare professionals to be able to distinguish biosimilars from the reference product. Additionally, biosimilars are not always accepted for substitution in a given jurisdiction, so it is important to avoid confusion when naming these products.


TGA Update


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