On July 28th, 2017 the Australian Therapeutic Goods Administration (TGA) announced that it was seeking comments from interested parties on the nomenclature for biologic medicines, including biosimilars. 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 BQ would assign a distinguishing suffix to biologics and biosimilars in order to aid in accurate identification and tracking.
From the comment letter:
The WHO INN Committee has been discussing approaches for global naming harmonization for several years, and ASBM has been engaged with this group since 2013. ASBM believes the WHO proposal to assign Biological Qualifier (BQ) suffixes —an alphabetic suffix assigned at random to a biological active substance manufactured at a specified site— is an easy-to-use model that can become a global standard, allowing for clear product identification, facilitating manufacturer accountability, and protecting patient safety. We were surprised that TGA did not list the adoption of the BQ for consideration as a potential naming option for biologic medicines. We encourage TGA to consider this as a naming option that will meet each of the outcomes sought, with the added benefit of enabling global naming harmonization.
ASBM met with the TGA and its parent agency the Australian Department of Health in February 2017 to share results of our survey of 160 Australian prescribers of biologic medicines. 76% of survey respondents supported TGA issuing distinct names for all biologics, including biosimilars.
Read the full comment letter here.