TGA Launches Biological Medicines Consultation
Australia’s Therapeutic Goods Administration announced a public consultation to collect feedback on possible changes to the agency’s biological naming conventions.
TGA currently assigns biosimilars and their references the same international nonproprietary name, the same system as the EMA. The FDA, however, has proposed adding a four-letter suffix to nonproprietary names.
The TGA is soliciting stakeholder comments on four possible scenarios — the status quo, the status quo with additional identifying information, or using a barcode or a suffix based-system.
Naming conventions that fail to distinguish biologics from biosimilars create the risk of harming patients when switching from one to the other, the agency said.