DenosumabCorora
Stoboclo for osteoporosis and established osteoporosis; Osenvelt for giant cell tumour of bone and bone metastases.
Decisions on record
- Meeting Nov 2025 Recommended Osteoporosis, giant cell tumour of bone, bone metastases
- Meeting Mar 2025 Recommended Giant cell tumour of bone and bone metastases
- Meeting Nov 2024 Recommended Osteoporosis; giant cell tumour of bone; bone metastases
- Meeting Nov 2021 Withdrawn Bisphosphonate-refractory hypercalcaemia of malignancy (HCM) no PSD
- Meeting Jul 2019 Not recommended The prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumours.
- Meeting Nov 2018 Not recommended Prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumours.
- Meeting Jul 2018 Not recommended Multiple myeloma (MM)
- Meeting Aug 2017 Recommended Osteoporosis no PSD
11 earlier decisions
- Jul 2016 Recommended Osteoporosis
- Jul 2016 Recommended Hypercalcaemia of malignancy
- Mar 2016 Not recommended Hypercalcaemia of malignancy
- Nov 2013 Recommended 120 mg/1.7 mL, injection, vial Amgen Australia Pty Ltd Major submission Giant cell tumour of bone Authority Required (STREAMLINED) listing for the treatment of giant cell tumour of bone in adult and skeletally mature adolescent patients. no treatment /placebo. The Committee considered that in the co
- Jul 2013 Recommended Osteoporosis
- Jul 2012 Recommended Bone metastases from prostate cancer or breast cancer no PSD
- Mar 2012 Recommended Bone metastases from prostate cancer
- Mar 2012 Recommended Osteoporosis
- Nov 2011 Recommended Osteoporosis no PSD
- Jul 2011 Recommended Bone metastases
- Jul 2010 Recommended Osteoporosis
Access path
- TGA registered · Corora
TGA label equal than the PBS population
- Jul 2010Recommended · restricted
Evidence: RCT → Meta-analysis
- Jul 2010Recommended · restricted
Evidence: RCT → Meta-analysis
- Jul 2011Recommended · restricted
Comparator changed: zoledronic acid → zoledronic acid 4 mg in 5 mL injection concentrate…
- Mar 2012Recommended · restricted
Comparator changed: zoledronic acid 4 mg in 5 mL injection concentrate for I.V. infusion…
- Mar 2012Recommended · restricted
Comparator changed: zoledronic acid 4 mg in 5 mL injection concentrate for I.V. infusion…
- Jul 2013Recommended
Comparator changed: alendronate → zoledronic acid
- Nov 2013Recommended
Comparator changed: zoledronic acid → no treatment/placebo
- Mar 2016Not recommended
inadequate comparative clinical evidence (naïve indirect comparison with high risk of bias, non-comparable study…
- ↻ resubmittedJul 2016Recommended · restricted
Comparator changed: zoledronic acid → pamidronate
- Jul 2016Recommended
Comparator changed: zoledronic acid → pamidronate
- Jul 2018Not recommended
uncertain clinical benefit in progression-free survival (exploratory outcome, high risk of bias, marginally…
- Nov 2018Not recommended
inadequate basis for accepting the claim of superior effectiveness compared to zoledronic acid, implausible…
- Jul 2019Not recommended
Comparator changed: zoledronic acid → zoledronic acid (main); pamidronate (secondary)
- ↻ resubmittedNov 2024Recommended
Comparator changed: zoledronic acid (main); pamidronate (secondary) → Prolia (60 mg…
- Mar 2025Recommended
Comparator changed: Prolia (60 mg reference brand) and Xgeva (120 mg reference brand) →…
- Nov 2025Recommended
Comparator changed: denosumab vial → Prolia (for Stoboclo); Xgeva (for Osenvelt)
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the General Schedule Authority Required (STREAMLINED) listings of two new denosumab biosimilars (Stoboclo® [Injection 60 mg in 1 mL pre- filled syringe] and Osenvelt® [Injection 120 mg in 1.7 mL]) on a cost-minimisation basis and under the same conditions as their reference biologics (Prolia® and Xgeva® respectively) for the same indications.PSD · Nov 2025
5.2 The PBAC advised the equi-effective doses to be 1 mg Stoboclo = 1 mg Prolia and 1 mg Osenvelt = 1 mg Xgeva.PSD · Nov 2025
5.10 The submission did not provide a cost-minimisation approach and requested the same approved ex-manufacturer price (AEMP) and dispensed price for maximum quantity (DPMQ) for denosumab PFS as that of denosumab vial, stating the PFS and vial are bioequivalent with an equi-effective dose of 1 x denosumab 120 mg PFS = 1 x denosumab 120 mg vial.PSD · Mar 2025
5.11 As a Category 4 submission, the economic analysis has not been independently evaluated.PSD · Mar 2025
5.8 The submission did not make any specific clinical claim. However, based on the content of the submission it is understood the applicant intends a claim of non-inferior comparative effectiveness and non-inferior comparative safety of denosumab PFS compared with denosumab vial.PSD · Mar 2025
5.9 The PBAC considered that the claim of non-inferior comparative effectiveness and safety was reasonable.PSD · Mar 2025
5.2 The PBAC noted and welcomed the input from individuals (3) and consumer group/organisations (1) via the Consumer Comments facility on the PBS website. The comments from the individuals emphasised the impact of myeloma on quality of life, particularly in reducing patients’ ability to participate in activities crucial for social and mental well-being.PSD · Mar 2025
5.3 The PBAC noted input received from Rare Cancers Australia that outlined several benefits of treatment with denosumab, including ease of administration through injection, reduced burden of daily medication, and improved overall quality of life.PSD · Mar 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as biosimilars are not expected to provide substantial clinical improvement over reference biologics.
The PBAC considered that the listings of Stoboclo and Osenvelt would not result in a net cost to the PBS as they would likely substitute for Prolia and Xgeva respectively and not increase the overall market utilisation. PBAC · 2025
Decision context
PopulationPatients eligible for denosumab under the same conditions and indications as the reference biologics Prolia and Xgeva.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | Prolia (for Stoboclo); Xgeva (for Osenvelt) | — | Cost-minimisation · Cost-minimisation |
| Mar 2025 | Recommended | denosumab vial | — | Single-arm · Surrogate |
| Nov 2024 | Recommended | Prolia (60 mg reference brand) and Xgeva (120 mg reference brand) | — | RCT · Bioequivalence |
| Jul 2019 | Not recommended | zoledronic acid (main); pamidronate (secondary) | — | RCT · Time to first on-study skeletal related event (SRE) |
| Nov 2018 | Not recommended | zoledronic acid | — | RCT · SRE (skeletal-related events) |
| Jul 2018 | Not recommended | zoledronic acid | — | RCT · SRE |
| Jul 2016 | Recommended · restricted | pamidronate | — | Single-arm · Cost-minimisation |
| Jul 2016 | Recommended | zoledronic acid | — | Single-arm · Other |
| Mar 2016 | Not recommended | zoledronic acid | — | Single-arm · Response rate |
| Nov 2013 | Recommended | no treatment/placebo | — | Single-arm · Surrogate |
| Jul 2013 | Recommended | zoledronic acid | — | RCT · Surrogate |
| Mar 2012 | Recommended · restricted | alendronate | — | RCT, indirect comparison · fracture outcomes (vertebral, non-vertebral, hip) |
| Mar 2012 | Recommended · restricted | alendronate | — | Meta-analysis |
| Jul 2011 | Recommended · restricted | zoledronic acid 4 mg in 5 mL injection concentrate for I.V. infusion | $100k–200k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Jul 2010 | Recommended · restricted | zoledronic acid | — | RCT · BMD, fracture outcomes |
| Jul 2010 | Recommended · restricted | zoledronic acid | — | Meta-analysis |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| Study 20062004 | Ph 4 | 85 | Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | completed |
| NCT03974100 | Ph 3 | 527 | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - Pe… | completed |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC population matches TGA label: biosimilars eligible under same conditions as reference biologics Prolia and Xgeva.