The TGA has launched a long awaited public consultation to gather feedback on proposals for potential biological naming systems, including options for aligning with systems proposed by the EU and the US.
Australia currently follows the European convention of assigning both biosimilars and their reference biologics the same international nonproprietary name (INN).
But selecting a naming convention for biologics has proved to be a contentious issue. A recent survey of Australian prescribers revealed that most agreed there was a need for a naming convention, but were divided on whether biosimilars should receive an identifying prefix, suffix, or completely unique name.
As previously reported by the limbic, the TGA has spent considerable time discussing the adoption of a naming convention for biosimilars with overseas regulators (see story here).
However given recent international developments the TGA says it now intends to consult on whether there is a need in Australia for additional naming requirements.
The European Medicines Agency (EMA) has said it will require a barcode on the packages of most medicines by 2019 that can be used for pharmacovigilance purposes to identify biologics manufacturers.
The FDA and the WHO have proposed naming conventions that would add a four-letter suffix to the nonproprietary names of all biologics.
For the public consultation, TGA is requesting input on the following proposals:
- Maintain the status quo;
- Maintain the status quo with additional activities to promote the inclusion of identifying information such as a product’s trade name, registered number (AUST R) and batch number in adverse event reports;
- Move towards adopting a barcode system similar to the EU; or
- Introduce the use of suffixes to the naming of biological medicines, similar to the US FDA.
For more detail click on the consultation and its proposed options click here.
Submissions must be put forward by the 8th September