Australian Government Announces Decision on Biosimilar Naming Conventions

Therapeutic Goods Administration (TGA) in Australia has announced that it will not use 4-letter suffixes in naming biologic and biosimilar medicines as the FDA currently requires.

The decision comes after several years of consideration and evaluation, and the adoption of different global approaches. When the time came to make a decision, the TGA considered 4 options:

• Maintaining the current system of using the Australian biological name without a specific identifier
• Introducing the United States’ 4-letter-suffix naming practices
• Maintaining the current system, but with the inclusion in adverse event (AE) reports of a product's name, AUST R number (a number assigned to Australian medicines assessed for safety, quality, and effectiveness), and batch number
• Introducing the European model of including a 2-dimensional barcode on the product package

TGA heard suggestions and concerns from various stakeholders in evaluating its decision. According to TGA, this decision is supported by most stakeholders. TAG’s position includes a future possible move toward adopting the EU’s barcode system, which incorporates the product code, national identification number, batch number, and expiry date.

In addition to the updated naming practice, the government also announced that its decision to strengthen AE reporting will include making the products’ brand name as well as non-proprietary name a mandatory field when reporting an AE.

The International Generic and Biosimilar medicines Association (IGBA) announced its support of the Australian Government’s decision to maintain the existing mandate for naming biologic and biosimilar medicines.

The government’s decision aligns with that of the European Union, which has approved the largest number of biosimilar medicines worldwide. The decision also aligns with the World Health Organization’s (WHO) approach to nomenclature.

The decision stands in contrast to the United States’ approach, however, whereby all biologics and biosimilars must have a 4-letter suffix, devoid of meaning, added to the end of newly approved biologics’ and biosimilars’ nonproprietary names. The first implementation of the FDA’s mandate to apply the suffix to newly approved innovator drugs came in November 2017 with the FDA approval of Roche’s Hemlibra (emicizumab-kxwh).