On January 24th, the Australian Therapeutic Goods Administration (TGA) released the response to its recent stakeholder consultation on biosimilar naming. The regulator sought input on whether or not it should use distinguishing suffixes for biologics and biosimilars to improve product identification and adverse event reporting. A suffix approach is currently supported by the World Health Organization, the U.S. FDA, and Health Canada. The TGA received 34 responses, which were divided on the merits of using distinguishing suffixes.
In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s Biological Qualifier (BQ) proposal. The distinct naming approach was also endorsed by Australian physician societies, patient advocacy organizations, and several biologic manufacturers.
Ultimately however, the TGA decided to continue to follow the approach used by the European Medicines Agency (using a biosimilar’s trade name in conjunction with a shared nonproprietary name) and work towards additional enhancements including the implementation of a machine-readable barcode on all biologics.
Read more about the TGA response here.