After a year of consultation, the TGA has rejected proposals for a unique naming system to differentiate biosimilar medicines from their biologic originators.
This week, the TGA announced it would not adopt an ARA-backed option to add a unique suffix to each biosimilar, but would instead maintain the current naming convention that relies on non-proprietary name and brand name .
The TGA says it favours a largely status quo option in a decision which it claims aligns with European Union and World Health Organisation (WHO) approaches.
The decision is a blow to the Australian Rheumatology Association, which advocated for a unique naming system in a submission to the TGA.
“In many ways, this is the ideal solution, particularly if it were possible to adopt an international standard, as has been suggested by the WHO,” the ARA submission said.
However, it acknowledged the new naming option faced significant challenges due to delays in WHO implementing a Biologic Qualifier (BQ) system.
“Meanwhile the FDA has mandated and executed a naming system as outlined in the [proposal] document. There are potential issues with this, including the naming of a biosimilar which is approved in Australia before it is available in the US,” it noted.
The ARA warned that failure to adopt a unique naming convention would likely lead to under-reporting and inaccurate attribution of adverse events and a failure to recognise loss of therapeutic response in the setting of repeated biosimilar switches and substitutions.
Also disappointed is industry lobby group Medicines Australia, which supported using a suffix identifier preceding a common ‘core’ non-proprietary name for biologics and biosimilars alike, arguing this would leave no room for ambiguity for patients, prescribers and pharmacists.
In its submission, Medicines Australia claimed with the increase in biosimilar copies set to enter the market, such differentiation will become more important to guard against errors in prescribing, dispensing or reporting adverse events.
The TGA plans to use a mandatory field to record the product’s trade name and batch number into its adverse event reporting system, to improve the identification of medicines behind adverse events.
Medicines Australia says this intervention will be “insufficient” unless coupled with naming changes, because familiarity with brand names may lead to “inadvertent misattribution” and some may abandon their report if all the relevant information is not at hand.
Meanwhile, the TGA’s course option was backed by the International Generic and Biosimilars Association (IGBA) which had “strongly opposed” the idea of a suffix, which it argued would be “expensive and unnecessary” but backed the idea of moving towards a barcode system, as long as there was further consultation.
Announcing the decision, the TGA said maintaining the status quo was supported by most respondents “either as a stand-alone option or as an initial approach with a future move towards adopting a barcode system similar to the European Union”.
The option would not add unnecessary regulatory burden or adversely impact the government’s new policy to encourage the uptake of biosimilar medicines.
It also “avoids the complexity and potential confusion that would be associated with introduction of a suffix-based system with retrospective coverage”.