On 5 November 2024, the Australian Register of Therapeutic Goods (ARTG), published 5 approvals of new brands for Amgen’s denosumab, confirming Amgen’s belief that biosimilar competition is imminent. This news follows Australian approval of Sandoz’s denosumab biosimilars, Jubbonti® and Wyost® in August 2024, and the consideration of the same at the November PBAC reimbursement meeting.
The new Australian brands which have not been approved anywhere else to date are:
- GANVADO and ZEROUNT – 70mg/mL vial; and
- CORORA, REXADEV and DEPTARGIS – 60mg/mL PFS with needle guard.
Earlier this year, in May 2024, Amgen entered into a partnership with generic giant Arrotex for the supply of Prolia® in Australia.
Amgen’s denosumab was first approved in Australia as Prolia® in June 2010 and as Xgeva® in September 2011.