On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting. This follows the PBAC’s publication of its September 2024 intracycle meeting outcomes, which noted that, to date, it had not received an acceptable proposal for an expanded listing to facilitate broad access to PD-(L)1 inhibitors which includes MSD’s pembrolizumab and BMS’ nivolumab.
For the March 2025 agenda, half of the submissions selected for consideration are for monoclonal antibodies, 17 of which are list for new PBS additions and 6 for amendments.
Four biosimilars will be considered for new listings:
- Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), for severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis, severe chronic plaque psoriasis, severe Crohn disease, complex refractory fistulising Crohn Disease, and moderate to severe ulcerative colitis
- Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), for relapsing-remitting multiple sclerosis
- Celltrion’s Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab), for uncontrolled severe asthma, uncontrolled severe allergic asthma, and severe chronic spontaneous urticaria
- Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, severe Crohn disease, and complex refractory fistulising Crohn Disease
One biosimilar is being considered for changes to an existing listing: Celltrion’s Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab).
Other applications for PBS listing additions or amendments that the PBAC will consider at its March 2025 meeting include the following:
| New listing applications: | Amendment Applications |
| Janssen’s Rybrevant® (amivantamab) in combination with Lazcluze® (lazertinib) for non-small cell lung cancer | Janssen’s Darzalex® (daratumumab) for multiple myeloma |
| Sanofi’s Dupixent® (dupilumab) for severe atopic dermatitis and uncontrolled severe asthma | Amgen’s Xgeva® (denosumab) for giant cell tumour of bone and bone metastases |
| Pfizer’s Elrexfio® (elranatamab) for relapsed or refractory multiple myeloma | MSD’s Keytruda® (pembrolizumab) for cervical cancer |
| Roche’s Vabysmo® (faricimab) for macular oedema secondary to retinal vein occlusion | Roche’s Perjeta® (pertuzumab) for HER2+ locally advanced, inflammatory or early stage breast cancer |
| Kyowa Kirin’s Poteligeo® (mogamulizumab) for cutaneous T-cell lymphoma | Alexion’s Ultomiris® (ravulizumab) for generalised myasthenia gravis |
| Sanofi’s Beyfortus® (nirsevimab) for the prevention of lower respiratory tract disease caused by respiratory syncytial virus | |
| Novartis’s Xolair® (omalizumab) for uncontrolled severe asthma, uncontrolled severe allergic asthma, and severe chronic spontaneous urticaria | |
| Roche’s Polivy® (polatuzumab vedotin) for diffuse large B-cell lymphoma | |
| UCB Australia’s Rystiggo® (rozanolixizumab) for generalised myasthenia gravis | |
| Amgen’s Imdelltra® (tarlatamab) for small cell lung cancer | |
| Amgen’s Tepezza® (teprotumumab) for thyroid eye disease | |
| Dr Reddy’s Zytorvi® (toripalimab) for nasopharyngeal carcinoma | |
| Astellas’s Vyloy® (zolbetuximab) for gastric or gastroesophageal junction cancer |