In 2017, the TGA opened a public consultation regarding the naming of biosimilars. The objective of this consultation was to determine whether biological medicines in Australia required additional naming requirements, in order to strengthen traceability and pharmacovigilance1.
The options proposed were1:
1. Maintain the status quo. Use the agreed Approved Biological Name to identify the active ingredient in both the reference product and all subsequent biosimilars. Unique identification of individual products would rely on its allocated Australian registration number (AUST R) and proprietary trade name.
2. Maintain the status quo with activities that increase public reporting of adverse events with the inclusion of the product’s trade name, AUST R and batch number. Currently the trade name is a non-mandated field on TGA’s forms for reporting adverse events as a prescriber who wishes to report an adverse event in relation to a patient may not know what product was supplied to the patient by the pharmacist. This option would focus on increasing education to healthcare professionals and the public to report all medicines, particularly biosimilars, associated with adverse events by their trade name, AUST R and with the associated batch number.
3. Move towards adopting a barcode system similar to the EU. The EU has mandated that most medicines supplied in the EU must have a unique identifier (a 2-dimensional barcode) placed on the packaging no later than February 2019. This bar code contains information including the product code, national identification number, batch number and expiry date. The barcode system allows traceability of batches of medicines from the manufacturer to individual patients as well as aiming to prevent falsified medicines entering the legal supply chain and improved pharmacovigilance
4. Introduce the use of suffixes to the naming of biological medicines. Use of suffixes to uniquely identify all biological medicines would be consistent with the approach taken by the US FDA. The FDA Approved Biological Name is to be used as the core name, but each product would have a unique suffix associated with the FDA Approved Biological Name. This option would make the biosimilar and reference biological brands appear as different drugs for prescribing purposes because they would be presented as distinct entries in prescribing lists and would therefore be displayed separately for the prescriber to choose from. This may undermine the scientific findings concerning their level of similarity.
Following the consultation, the TGA has decided it is not necessary to add a brand specific suffix and will maintain the current naming convention for biosimilars, keeping Australia’s nomenclature in line with that of the European Medicines Agency (EMA). Adverse event reporting will be strengthened, via making the product’s trade name and non-proprietary name a mandatory field when reporting an adverse event to TGA2.
References:
1. TGA. Consultation: Nomenclature of Biological Medicines, 2017. Available at https://www.tga.gov.au/sites/default/files/consultation-nomenclature-biological-medicines.pdf. Accessed April 2018.
2. TGA. Submissions received and TGA response: Nomenclature of biological medicines. Available at: https://www.tga.gov.au/submissions-received-and-tga-response-nomenclature-biological-medicines. Accessed April 2018.
Med184. Prepared April 2018.
