The TGA is sticking with single names when it comes to the naming of biologic and biosimilar medicines.
The decision follows several years of consideration, extensive consultation, and the adoption of different approaches globally.
In its official response, the regulator said stakeholder submissions "showed broad stakeholder support for additional mechanisms to collect information to allow investigation into adverse events for biological and biosimilar medicines."
It continued, "Stakeholders feedback was used to inform the Government's decision to maintain the existing naming convention for biological and biosimilar medicines, that is continue using the Australian biological name (without a specific identifier suffix) and strengthen our adverse event reporting."
The TGA considered four options. In addition to retention of the status quo, under which biologics and their biosimilars are given the same name, it proposed introduction of the US-style unique identifier for biologic medicines. It also proposed retention of the status quo with the inclusion in adverse event reports of a product’s trade name, AUST R and batch number. The fourth option was the European 2D barcode on product packaging.
In its response, the TGA said its "posture" was supported by most stakeholders, including in relation to the retention of the single name with a possible future move to adopting the EU's barcode system, which incorporates the product code, national identification number, batch number and expiry date.
The regulator also said retention of the single name would not "adversely impact" government's biosimilar awareness initiative.
It added implementation will involve product's trade name a mandatory field when reporting an adverse event.