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Sandoz’s High Concentration Adalimumab Biosimilar on AU July PBAC Agenda

Apr 3, 2024

On 3 April 2024, Australia’s PBAC published the July 2024 Meeting Agenda.  On the list of drugs seeking to be PBS reimbursed is Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab).  Hyrimoz® is currently PBS-listed in a 40mg/0.8mL form and reimbursement is now being sought for 20mg/0.2mL, 40mg/0.4ml and 80mg/0.8ml forms.

Sandoz launched its high concentration formulation of Hyrimoz® in Europe in November 2023 and in the US in July 2023.

Also on the PBAC July Agenda are applications for new PBS-listings of:

  • Eisai’s Leqembi® (lecanemab) for the treatment of early Alzheimer’s disease and Pfizer’s multiple myeloma treatment Elrexfio® (elranatamab), which are each yet to be TGA-approved; and
  • Sanofi’s Beyfortux® (nirsevimab) for the prevention of respiratory syncytial virus in babies, approved by the TGA in November 2023.

Roche has applied to PBS-list a new indication (retinal vein occlusion) and new PFS form of its Vabysmo® (faricimab).

BMS is seeking to vary the existing listings for nivolumab and ipilimumab, and Takeda is seeking authority script listing for vedolizumab for continuing treatment of chronic pouchitis.

The reimbursement of Novo Nordisk’s PBS listed Ozempic® (semaglutide) (and other GLP-1 analogues) for the treatment of type 2 diabetes mellitus will also be considered.