The TGA is still waiting on global developments before finalising its naming convention for biologic and biosimilar medicines.
The issue, which is considered a pivotal step in the development of the biosimilar market, has been an ongoing global focus of industry and regulatory agencies for several years.
In Australia, the TGA scrapped the naming convention it adopted in 2013 in late 2015. Under the scrapped convention, biosimilars were approved with names including the originator biologic and an additional identifier. Under its current convention, biosimilars are simply given the same name as their originator biologic.
In response to a question on notice from Greens leader Richard Di Natale at recent Supplementary Budget Estimates, the Department of Health said the outcome of the TGA's ongoing review of its naming convention is dependent on a similar review by the World Health Organisation (WHO), "and developments in nomenclature by the US Food and Drug Administration (FDA)."
"As they have not yet announced their final nomenclature policy, there is no proposed date for finalisation at this stage…Once the WHO and the US FDA have published their policies, the TGA will review and consult appropriately with stakeholders. Currently external stakeholders are involved via the TGA’s Industry Working Group," said the Department in its response.
The WHO released a proposed guideline for the naming of biosimilars earlier this year, recommending the adoption of a Biological Qualifier (BQ) for all biological substances. Under the proposal, the BQ code will be comprised of four random consonants in two 2-letter blocks separated by a 2-digit checksum.
The TGA is understood to have previously told stakeholders it is likely to adopt the finalised WHO system.
"The TGA aims to be internationally aligned with other regulatory bodies with respect to therapeutic goods regulation," it said in its response to Senator Di Natale. "The TGA is represented on the International Nonproprietary Names Committee and has had input on the development of policy on the naming of all biological medicines which includes biosimilars. Representatives from regulators from the US, Europe, UK, Japan, Canada, China and Brazil also have input into this policy. In this forum, there is significant interchange of ideas and policy decisions."