- Biosimilars eligible for streamlined authority PBS listing3
- Biosimilars can apply for a streamlined authority PBS listing, eliminating the need for prescribing physicians to complete paperwork and obtain prior approval, substantially decreasing the administrative burden.
- The originator (and any clone) remains as a full authority script.
- Treatment naive patients are recommended to be initiated on the biosimilar3
- BA prescribing recommendation is added for products where a biosimilar is available on the PBS, to encourage prescribers to initiate all new patients on the biosimilar.
- Maintaining the current naming convention – Australian Biological Names (ABN) do not require a brand specific suffix4
- Following extensive consultation and advice, the TGA has determined that it is not necessary to add a brand specific suffix to the ABN of biosimilar medicines in order to distinguish between them in pharmacovigilance reporting.
- This decision keeps the naming of biosimilars in Australia in line with the European Union guidelines
- ‘A-Flagging’ some biologic and biosimilar medicines5
- Some biosimilar medicines are ‘a-flagged’ with their reference biologic, allowing for substitution at pharmacy level, due to the high degree of similarity between the two products.
- When deciding to ‘a-flag’ a biosimilar with its reference biologic, the Pharmaceutical Benefits Advisory Committee (PBAC) considers the comparative data on clinical safety and efficacy, availability of data to support switching, high risk patient populations, data on initiating treatment-naïve patients on the biosimilar and whether the TGA has deemed a product to be biosimilar with the reference.
1. IMS Health. Sept 2017. 2. Pharmaceutical Benefits Scheme to be reformed [media release]. Department of Health, Australia; May 27, 2015. Available at: https://bit.ly/2q3xQp0. Accessed April 2018. 3. Australian Department of Health. Biosimilar Uptake Drivers. Available at: https://bit.ly/2GuastK. Accessed April 2018. 4. TGA. Biosimilar medicines regulation. Available at: https://bit.ly/2JftR3w. Accessed April 2018. 5. Australian Department of Health. Who chooses whether the biosimilar medicine or the reference biological medicine is used? 23 March, 2017. Available at: https://bit.ly/2GuT4cg. Accessed April 2018.