DENOSUMAB

Information current as at: 1 July 2026

PBAC meeting date: November 2026
Legend: Completed N In progress Not applicable N Yet to commence

Submission Details

Brand name:
  • Denolia®
  • Deskelta®
  • Dexeva®
  • Dostiva®
Form and strength:
  • Injection 60 mg in 1 mL pre-filled syringe
  • Injection 120 mg in 1.7 mL pre-filled syringe
Submission sponsor:
ACCORD HEALTHCARE PTY. LTD.
Condition/indication:
(therapeutic use)
  • Osteoporosis Bone metastases Giant cell tumour of bone
Listing requested:
To request listing of four new denosumab biosimilars that mirror their respective originator brand’s current listings.
Funding program:
PBS General Schedule
Request authority level:
Authority Required (STREAMLINED)
PBAC Submission type:
New PBS listing (–)
Comment:
--
Other PBAC consideration:
--

Progress Details

Submission received for:
November 2026 PBAC meeting
2Opportunity for consumer comment:
Open 22/07/2026 and close 16/09/2026 (see PBS Website)
3PBAC meeting:
Has not yet occurred
4PBAC outcome published:
Pending PBAC outcome (see PBAC Outcomes)
5Lodgement of required documentation:
6Agreement to listing arrangements:
Has not yet commenced
7Government processes:
Has not yet commenced
8Medicine listed on the PBS:
Has not yet occurred

PBAC Outcome

PBAC Recommendation:
Please see the Outcomes from the relevant meeting for more information

Case ID
a1272
Page last updated
23 July 2026
v.9.19