SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| Densibon | 60 mg/ml | Solution for injection in pre-filled syringe · Subcutaneous use | 1 Pre-filled syringe | SAR 730.50 | Biological · Prescription | MS Pharma Saudi (MSPS) | Valid |
| PROLIA 60MG/ML SOLUTION FOR INJECTION | 60 mg/ml | Solution for injection in pre-filled syringe · Subcutaneous use | 1 Pre-filled syringe | SAR 974.00 | NCE · Prescription | AMGEN EUROPE B.V. | Valid |
| XGEVA 120 mg solution for injection | 70 mg/ml | Solution for injection · Subcutaneous use | 1 Vial | SAR 1623.00 | NCE · Prescription | AMGEN EUROPE B.V. | Valid |
| Xodema | 70 mg/ml | Solution for injection · Subcutaneous use | 1 Vial | SAR 1217.25 | Biological · Prescription | MS Pharma Saudi (MSPS) | Valid |
Indications — CHI Daman Drug Formulary
BREAST CANCER MET. HORMONAL-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET. HORMONAL-SUPPORTIVE CARE; BREAST CANCER MET.HER-2 +VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET.HER-2 -VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER TARGET THERAPY-ADVERSE REACTION MANAGEMENT; BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HYPERPARATHYRODISM; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA-HYPERCALCEMIA OF MALIGNANCY; OSTEOPOROSIS; PROSTATE CANCER; THYROID CANCER-MEDULLARY CARCINOMA-SUPPORTIVE CARE
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| PROLIA | 60MG/ML | injectable · subcutaneous | AMGEN | Prescription | 1 Jun 2010 |
| XGEVA | 70MG/ML | injectable · subcutaneous | AMGEN | Prescription | 1 Jun 2010 |
| JUBBONTI | 60MG/ML | injectable · subcutaneous | SANDOZ INC | Prescription | 5 Mar 2024 |
| WYOST | 120MG/1.7ML (70MG/ML) | injectable · subcutaneous | SANDOZ INC | Prescription | 5 Mar 2024 |
| OSPOMYV | 60MG/ML | injectable · subcutaneous | SAMSUNG BIOEPIS CO LTD | Prescription | 13 Feb 2025 |
| XBRYK | 70MG/ML | injectable · subcutaneous | SAMSUNG BIOEPIS CO LTD | Prescription | 13 Feb 2025 |
| DENOSUMAB-DSSB | 60MG/ML; 70MG/ML | injectable · subcutaneous | SAMSUNG BIOEPIS CO LTD | Prescription | 13 Feb 2025 |
| STOBOCLO | 60MG/ML | injectable · injection | CELLTRION INC | Prescription | 28 Feb 2025 |
| OSENVELT | 120MG/1.7ML(70MG/ML) | injectable · injection | CELLTRION INC | Prescription | 28 Feb 2025 |
| BOMYNTRA | 120MG/1.7ML (70 MG/ML) | injection | FRESENIUS KABI USA LLC | Prescription | 25 Mar 2025 |
| CONEXXENCE | 60MG/ML | injection | FRESENIUS KABI USA LLC | Prescription | 25 Mar 2025 |
| BILDYOS | 60MG/ML | injectable · injection | SHANGHAI HENLIUS BIOTECH | Prescription | 29 Aug 2025 |
| BILPREVDA | 120MG/1.7ML(70MG/ML) | injectable · injection | SHANGHAI HENLIUS BIOTECH | Prescription | 29 Aug 2025 |
| AUKELSO | 120MG/1.7ML(70MG/ML) | injectable · injection | BIOCON BIOLOGICS INC | Prescription | 16 Sep 2025 |
| BOSAYA | 60MG/ML | injectable · injection | BIOCON BIOLOGICS INC | Prescription | 16 Sep 2025 |
| ENOBY | 60MG/ML | solution · injection | HIKMA PHARMACEUTICALS USA INC | Prescription | 26 Sep 2025 |
| XTRENBO | 120MG/1.7ML(70MG/ML) | solution · injection | HIKMA PHARMACEUTICALS USA INC | Prescription | 26 Sep 2025 |
| OSVYRTI | 60MG/ML | injectable · subcutaneous | ACCORD BIOPHARMA INC. | Prescription | 29 Oct 2025 |
| JUBEREQ | 120MG/1.7ML | injectable · subcutaneous | ACCORD BIOPHARMA INC. | Prescription | 29 Oct 2025 |
| BONCRESA | 60MG/ML | injectable · subcutaneous | AMNEAL PHARMS LLC | Prescription | 19 Dec 2025 |
| OZILTUS | 120MG/1.7ML (70MG/ML) | injectable · subcutaneous | AMNEAL PHARMS LLC | Prescription | 19 Dec 2025 |
| PONLIMSI | 60MG/ML | injectable · subcutaneous | TEVA PHARMACEUTICALS, INC. | Prescription | 27 Mar 2026 |
| DEGEVMA | 120MG/1.7ML (70MG/ML) | injectable · subcutaneous | TEVA PHARMACEUTICALS, INC. | Prescription | 25 Sep 2026 |
EMA European Union — centrally authorised medicines
Prolia Amgen Europe B.V. · Authorised · authorised 26 May 2010 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
Xgeva Amgen Europe B.V. · Authorised · authorised 13 Jul 2011 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Jubbonti Sandoz GmbH · Authorised · authorised 16 May 2024 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
Wyost Sandoz GmbH · Authorised · authorised 17 May 2024 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Obodence Samsung Bioepis NL B.V. · Authorised · authorised 12 Feb 2025 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
Xbryk Samsung Bioepis NL B.V. · Authorised · authorised 12 Feb 2025 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Stoboclo Celltrion Healthcare Hungary Kft. · Authorised · authorised 14 Feb 2025 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
Osenvelt Celltrion Healthcare Hungary Kft. · Authorised · authorised 14 Feb 2025 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Jubereq Accord Healthcare S.L.U. · Authorised · authorised 26 May 2025 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Osvyrti Accord Healthcare S.L.U. · Authorised · authorised 26 May 2025 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
Junod Gedeon Richter Plc. · Authorised · authorised 23 Jun 2025 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Junod significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Junod significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
Yaxwer Gedeon Richter Plc. · Authorised · authorised 23 Jun 2025 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Vevzuo Biosimilar Collaborations Ireland Limited · Authorised · authorised 25 Jun 2025 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Izamby Mabxience Research SL · Authorised · authorised 26 Jun 2025 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Izamby significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
Denbrayce Mabxience Research SL · Authorised · authorised 26 Jun 2025 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Enwylma Zentiva k.s. · Authorised · authorised 26 Jun 2025 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Zadenvi Zentiva k.s. · Authorised · authorised 26 Jun 2025 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, ZADENVI significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
Evfraxy Biosimilar Collaborations Ireland Limited · Authorised · authorised 30 Jun 2025 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Evfraxy significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Evfraxy significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
Bomyntra Fresenius Kabi Deutschland GmbH · Authorised · authorised 17 Jul 2025 · ATC M05BX04
Therapeutic indication (EMA)
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Rolcya Sandoz GmbH · Authorised · authorised 17 Jul 2025 · ATC M05BX04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
12 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| BILDYOS | 02565951 | 60 MG / ML | SOLUTION · SUBCUTANEOUS | SHANGHAI HENLIUS BIOTECH, INC. |
| DENOZA | 02566265 | 60 MG / ML | SOLUTION · SUBCUTANEOUS | APOTEX INC |
| IDENOS | 02566273 | 120 MG / 1.7 ML | SOLUTION · SUBCUTANEOUS | APOTEX INC |
| JUBBONTI | 02545411 | 60 MG / ML | SOLUTION · SUBCUTANEOUS | SANDOZ CANADA INCORPORATED |
| OSENVELT | 02560895 | 120 MG / 1.7 ML | SOLUTION · SUBCUTANEOUS | CELLTRION INC. |
| PROLIA | 02343541 | 60 MG / ML | SOLUTION · SUBCUTANEOUS | AMGEN CANADA INC |
| STOBOCLO | 02560917 | 60 MG / ML | SOLUTION · SUBCUTANEOUS | CELLTRION INC. |
| TUZEMTY | 02566001 | 120 MG / 1.7 ML | SOLUTION · SUBCUTANEOUS | SHANGHAI HENLIUS BIOTECH, INC. |
| WYOST | 02545764 | 120 MG / 1.7 ML | SOLUTION · SUBCUTANEOUS | SANDOZ CANADA INCORPORATED |
| XGEVA | 02368153 | 120 MG / 1.7 ML | SOLUTION · SUBCUTANEOUS | AMGEN CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | BILDYOS 60 MG/ML SYRINGE | $814.13419 | per ML | 23 Sep 2026 |
| US NADAC | CONEXXENCE 60 MG/ML SYRINGE | $1740.44875 | per ML | 23 Sep 2026 |
| US NADAC | JUBBONTI 60 MG/ML SYRINGE | $1536.90512 | per ML | 23 Sep 2026 |
| US NADAC | PROLIA 60 MG/ML SYRINGE | $1862.74398 | per ML | 23 Sep 2026 |
| US NADAC | STOBOCLO 60 MG/ML SYRINGE | $1582.15435 | per ML | 23 Sep 2026 |
| US NADAC | XGEVA 120 MG/1.7 ML VIAL | $2001.51678 | per ML | 7 Jan 2026 |
| NHS Drug Tariff | Denosumab 120mg/1.7ml solution for injection vials | £309.86 | 1 vial | 1 Oct 2026 |
| NHS Drug Tariff | Denosumab 60mg/1ml solution for injection pre-filled syringes | £183.00 | 1 pre-filled disposable injection | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.