The Australian Pharmaceutical Benefits Assessment Committee (PBAC) November meeting promises to be a significant one for biopharmaceuticals based on the agenda published on 31 July 2024.
Two biosimilars will be considered: Sandoz’s Wyost® (denosumab) (biosimilar to Amgen’s Prolia®/Xgeva®) and Celltrion’s Steqeyma® (ustekinumab) (biosimilar to Janssen’s Stelara®). Neither of these have yet received marketing approval.
Bayer is seeking listing on the Pharmaceutical Benefits Scheme (PBS) for an indication expansion for its Eylea® (aflibercept) for diabetic macular oedema and subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD). MSD has applied for listing of a new strength of Ozempic® (semaglutide) (solution for injection 2 mg in 3 mL pre-filled pen) for type 2 diabetes.
Applications for PBS listing additions or amendments that the PBAC will consider at its November 2024 meeting include the following:
| New Listing | Amendment Applications |
| Janssen’s Rybrevant® (amivantamab) for non-small cell lung cancer (NSCLC), | Astellas Pharma’s Padcev® (enfortumab vedotin) |
| Sandoz’s Wyost® (denosumab) (biosimilar to Amgen’s Prolia®/Xgeva®) for osteoporosis, giant cell tumour of bone, bone metastases | Astra Zeneca’s Lynparza® (olaparib) |
| AbbVie’s Epkinly® (epcoritamab) for diffuse large B cell lymphoma | Novartis’ Kesimpta® (ofatumumab) |
| Novartis’ Aimovig® (erenumab) for chronic migraine | BMS’s Opdivo® (nivolumab) |
| CSL’s garadacimab for hereditary angioedema | MSD’s Keytruda® (pembrolizumab) |
| Takeda’s Takhzyro® (lanadelumab) for hereditary angioedema | Alexion’s Ultomiris® (ravulizumab) |
| Beigene’s Tevimbra® (tiselizumab) for oesophageal squamous cell carcinoma (OSCC) | Novo Nordisk’s Ozempic® (semaglutide) |
| Celltrion’s Steqeyma (ustekinumab) (biosimilar to Janssen’s Stelara®) for severe chronic plaque psoriasis, severe psoriatic arthritis, Crohn’s disease |