On 23 August 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its July 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals.
The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):
- Sandoz’s Hyrimoz® (adalimumab) for the same indications as the currently PBS-listed reference biologic, Abbvie’s Humira®, and other brands of adalimumab.
In addition, the following originator biopharmaceuticals were recommended for PBS listing:
- Roche’s Vabysmo® (faricimab) for the treatment of retinal vein occlusion.
- AstraZeneca’s Lynparza® (olaparib) for the treatment of HER2-negative metastatic breast cancer for patients with a confirmed BRCA1 or BRCA2 mutation.
- Takeda’s Entyvio® (vedolizumab) for continuing treatment of chronic pouchitis.
PBAC reports that MSD’s Keytruda® (pembrolizumab) solution concentrate for IV infusion 100 mg in 4 mL has had its May 2022 recommendation extended for an additional 12 months. Janssen’s Stelara® (ustekinumab) injection 90 mg in 1 mL pre-filled syringe has had its July 2022 recommendation rescinded.
In August 2024, we reported that a number of biopharmaceuticals and biosimilars are potentially in line for September listings on the PBS, including two biosimilars to Abbvie’s Humira® (adalimumab): Organon’s Hadlima® (adalimumab-bwwd) in 40 mg/0.4 ml PFP and Celltrion’s Yuflyma® (adalimumab-aaty) in 0.8 mg/0.8 ml PFN and PFS.