| 0143-9165 | These highlights do not include all the information needed to use ENOBY™ safely and effectively. See full prescribing information for ENOBY. ENOBY™ (denosumab-qbde) injection, for subcutaneous use Initial U.S. Approval: 2025 ENOBY™ (denosumab-qbde) is biosimilar* to PROLIA ® (denosumab). | Hikma Pharmaceuticals USA Inc. |
| 0143-9165-01 | These highlights do not include all the information needed to use ENOBY™ safely and effectively. See full prescribing information for ENOBY. ENOBY™ (denosumab-qbde) injection, for subcutaneous use Initial U.S. Approval: 2025 ENOBY™ (denosumab-qbde) is biosimilar* to PROLIA ® (denosumab). | Hikma Pharmaceuticals USA Inc. |
| 0143-9166 | These highlights do not include all the information needed to use XTRENBO™ safely and effectively. See full prescribing information for XTRENBO. XTRENBO™ (denosumab-qbde) injection, for subcutaneous use Initial U.S. Approval: 2025 XTRENBO™ (denosumab-qbde) is biosimilar* to XGEVA ® (denosumab). | Hikma Pharmaceuticals USA Inc. |
| 0143-9166-01 | These highlights do not include all the information needed to use XTRENBO™ safely and effectively. See full prescribing information for XTRENBO. XTRENBO™ (denosumab-qbde) injection, for subcutaneous use Initial U.S. Approval: 2025 XTRENBO™ (denosumab-qbde) is biosimilar* to XGEVA ® (denosumab). | Hikma Pharmaceuticals USA Inc. |
| 55513-710 | These highlights do not include all the information needed to use PROLIA safely and effectively. See full prescribing information for PROLIA. PROLIA ® (denosumab) injection, for subcutaneous use Initial U.S. Approval: 2010 | Amgen, Inc | Amgen Manufacturing Limited LLC |
| 55513-710-01 | These highlights do not include all the information needed to use PROLIA safely and effectively. See full prescribing information for PROLIA. PROLIA ® (denosumab) injection, for subcutaneous use Initial U.S. Approval: 2010 | Amgen, Inc | Amgen Manufacturing Limited LLC |
| 55513-710-21 | These highlights do not include all the information needed to use PROLIA safely and effectively. See full prescribing information for PROLIA. PROLIA ® (denosumab) injection, for subcutaneous use Initial U.S. Approval: 2010 | Amgen, Inc | Amgen Manufacturing Limited LLC |
| 55513-730 | These highlights do not include all the information needed to use X GEVA ® safely and effectively. See full prescribing information for X GEVA . Xgeva ( denosumab ) i njection , for subcutaneous u se Initial U.S. Approval: 2010 | Amgen, Inc | Amgen Manufacturing Limited LLC |
| 55513-730 | These highlights do not include all the information needed to use X GEVA ® safely and effectively. See full prescribing information for X GEVA . Xgeva ( denosumab ) i njection , for subcutaneous u se Initial U.S. Approval: 2010 | Amgen, Inc |
| 55513-730-01 | These highlights do not include all the information needed to use X GEVA ® safely and effectively. See full prescribing information for X GEVA . Xgeva ( denosumab ) i njection , for subcutaneous u se Initial U.S. Approval: 2010 | Amgen, Inc | Amgen Manufacturing Limited LLC |
| 55513-730-01 | These highlights do not include all the information needed to use X GEVA ® safely and effectively. See full prescribing information for X GEVA . Xgeva ( denosumab ) i njection , for subcutaneous u se Initial U.S. Approval: 2010 | Amgen, Inc |
| 55513-730-21 | These highlights do not include all the information needed to use X GEVA ® safely and effectively. See full prescribing information for X GEVA . Xgeva ( denosumab ) i njection , for subcutaneous u se Initial U.S. Approval: 2010 | Amgen, Inc | Amgen Manufacturing Limited LLC |
| 55513-730-21 | These highlights do not include all the information needed to use X GEVA ® safely and effectively. See full prescribing information for X GEVA . Xgeva ( denosumab ) i njection , for subcutaneous u se Initial U.S. Approval: 2010 | Amgen, Inc |
| 61314-228 | These highlights do not include all the information needed to use WYOST ® safely and effectively. See full prescribing information for WYOST. WYOST ® (denosumab-bbdz) injection, for subcutaneous use Initial U.S. Approval: 2024 WYOST (denosumab-bbdz) is biosimilar* to XGEVA ® (denosumab). | Sandoz Inc |
| 61314-228-94 | These highlights do not include all the information needed to use WYOST ® safely and effectively. See full prescribing information for WYOST. WYOST ® (denosumab-bbdz) injection, for subcutaneous use Initial U.S. Approval: 2024 WYOST (denosumab-bbdz) is biosimilar* to XGEVA ® (denosumab). | Sandoz Inc |
| 61314-240 | These highlights do not include all the information needed to use JUBBONTI ® safely and effectively. See full prescribing information for JUBBONTI. JUBBONTI ® (denosumab-bbdz) injection, for subcutaneous use Initial U.S. Approval: 2024 JUBBONTI (denosumab-bbdz) is biosimilar* to PROLIA ® (denosumab). | Sandoz Inc |
| 61314-240-63 | These highlights do not include all the information needed to use JUBBONTI ® safely and effectively. See full prescribing information for JUBBONTI. JUBBONTI ® (denosumab-bbdz) injection, for subcutaneous use Initial U.S. Approval: 2024 JUBBONTI (denosumab-bbdz) is biosimilar* to PROLIA ® (denosumab). | Sandoz Inc |
| 65219-668 | These highlights do not include all the information needed to use CONEXXENCE safely and effectively. See full prescribing information for CONEXXENCE. CONEXXENCE (denosumab-bnht) injection, for subcutaneous use Initial U.S. Approval: 2025 CONEXXENCE (denosumab-bnht) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differen | Fresenius Kabi USA, LLC |
| 65219-668-01 | These highlights do not include all the information needed to use CONEXXENCE safely and effectively. See full prescribing information for CONEXXENCE. CONEXXENCE (denosumab-bnht) injection, for subcutaneous use Initial U.S. Approval: 2025 CONEXXENCE (denosumab-bnht) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differen | Fresenius Kabi USA, LLC |
| 65219-670 | These highlights do not include all the information needed to use BOMYNTRA safely and effectively. See full prescribing information for BOMYNTRA. BOMYNTRA (denosumab-bnht) injection, for subcutaneous use Initial U.S. Approval: 2025 BOMYNTRA (denosumab-bnht) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betw | Fresenius Kabi USA, LLC |
| 65219-670-01 | These highlights do not include all the information needed to use BOMYNTRA safely and effectively. See full prescribing information for BOMYNTRA. BOMYNTRA (denosumab-bnht) injection, for subcutaneous use Initial U.S. Approval: 2025 BOMYNTRA (denosumab-bnht) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betw | Fresenius Kabi USA, LLC |
| 65219-672 | These highlights do not include all the information needed to use BOMYNTRA safely and effectively. See full prescribing information for BOMYNTRA. BOMYNTRA (denosumab-bnht) injection, for subcutaneous use Initial U.S. Approval: 2025 BOMYNTRA (denosumab-bnht) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betw | Fresenius Kabi USA, LLC |
| 65219-672-01 | These highlights do not include all the information needed to use BOMYNTRA safely and effectively. See full prescribing information for BOMYNTRA. BOMYNTRA (denosumab-bnht) injection, for subcutaneous use Initial U.S. Approval: 2025 BOMYNTRA (denosumab-bnht) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betw | Fresenius Kabi USA, LLC |
| 70121-2701 | These highlights do not include all the information needed to use OZILTUS safely and effectively. See full prescribing information for OZILTUS. OZILTUS ® (denosumab-mobz) injection, for subcutaneous use Initial U.S. Approval: 2010 OZILTUS (denosumab-mobz) is biosimilar* to XGEVA ® (denosumab) | Amneal Pharmaceuticals LLC |
| 70121-2701-1 | These highlights do not include all the information needed to use OZILTUS safely and effectively. See full prescribing information for OZILTUS. OZILTUS ® (denosumab-mobz) injection, for subcutaneous use Initial U.S. Approval: 2010 OZILTUS (denosumab-mobz) is biosimilar* to XGEVA ® (denosumab) | Amneal Pharmaceuticals LLC |
| 70121-2702 | These highlights do not include all the information needed to use BONCRESA safely and effectively. See full prescribing information for BONCRESA. BONCRESA ® (denosumab-mobz) injection, for subcutaneous use Initial U.S. Approval: 2010 BONCRESA (denosumab-mobz) is biosimilar* to PROLIA ® (denosumab) | Amneal Pharmaceuticals LLC |
| 70121-2702-1 | These highlights do not include all the information needed to use BONCRESA safely and effectively. See full prescribing information for BONCRESA. BONCRESA ® (denosumab-mobz) injection, for subcutaneous use Initial U.S. Approval: 2010 BONCRESA (denosumab-mobz) is biosimilar* to PROLIA ® (denosumab) | Amneal Pharmaceuticals LLC |
| 71202-012 | These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV. OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Initial U.S. Approval: 2025 OSPOMYV (denosumab-dssb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between | Samsung Bioepis Co., Ltd., | Samsung Biologics Co., Ltd. | FARMACEUTICI FORMENTI SPA |
| 71202-012-10 | These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV. OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Initial U.S. Approval: 2025 OSPOMYV (denosumab-dssb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between | Samsung Bioepis Co., Ltd., | Samsung Biologics Co., Ltd. | FARMACEUTICI FORMENTI SPA |
| 71202-012-11 | These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV. OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Initial U.S. Approval: 2025 OSPOMYV (denosumab-dssb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between | Samsung Bioepis Co., Ltd., | Samsung Biologics Co., Ltd. | FARMACEUTICI FORMENTI SPA |
| 72606-037 | These highlights do not include all the information needed to use STOBOCLO safely and effectively. See full prescribing information for STOBOCLO. STOBOCLO ® (denosumab-bmwo) injection, for subcutaneous use Initial U.S. Approval: 2025 STOBOCLO ® (denosumab-bmwo) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences | CELLTRION USA, Inc. |
| 72606-037-01 | These highlights do not include all the information needed to use STOBOCLO safely and effectively. See full prescribing information for STOBOCLO. STOBOCLO ® (denosumab-bmwo) injection, for subcutaneous use Initial U.S. Approval: 2025 STOBOCLO ® (denosumab-bmwo) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences | CELLTRION USA, Inc. |
| 72606-038 | These highlights do not include all the information needed to use OSENVELT safely and effectively. See full prescribing information for OSENVELT. OSENVELT ® (denosumab-bmwo) injection, for subcutaneous use Initial U.S. Approval: 2025 OSENVELT ® (denosumab-bmwo) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences | CELLTRION USA, Inc. |
| 72606-038-01 | These highlights do not include all the information needed to use OSENVELT safely and effectively. See full prescribing information for OSENVELT. OSENVELT ® (denosumab-bmwo) injection, for subcutaneous use Initial U.S. Approval: 2025 OSENVELT ® (denosumab-bmwo) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences | CELLTRION USA, Inc. |
| 72606-058 | These highlights do not include all the information needed to use DENOSUMAB-BMWO safely and effectively. See full prescribing information for DENOSUMAB-BMWO. DENOSUMAB-BMWO injection, for subcutaneous use Initial U.S. Approval: 2025 Denosumab-bmwo is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the bi | CELLTRION USA, Inc. |
| 72606-058-01 | These highlights do not include all the information needed to use DENOSUMAB-BMWO safely and effectively. See full prescribing information for DENOSUMAB-BMWO. DENOSUMAB-BMWO injection, for subcutaneous use Initial U.S. Approval: 2025 Denosumab-bmwo is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the bi | CELLTRION USA, Inc. |
| 72606-059 | These highlights do not include all the information needed to use DENOSUMAB-BMWO safely and effectively. See full prescribing information for DENOSUMAB-BMWO. DENOSUMAB-BMWO injection, for subcutaneous use Initial U.S. Approval: 2025 Denosumab-bmwo is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the bi | CELLTRION USA, Inc. |
| 72606-059-01 | These highlights do not include all the information needed to use DENOSUMAB-BMWO safely and effectively. See full prescribing information for DENOSUMAB-BMWO. DENOSUMAB-BMWO injection, for subcutaneous use Initial U.S. Approval: 2025 Denosumab-bmwo is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the bi | CELLTRION USA, Inc. |
| 78206-193 | These highlights do not include all the information needed to use BILDYOS safely and effectively. See full prescribing information for BILDYOS. BILDYOS ® (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILDYOS ® (denosumab-nxxp) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betw | Organon LLC | Shanghai Henlius Biotech, Inc. | Shanghai Henlius Biologics Co.,Ltd. | Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 | WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd. |
| 78206-193 | These highlights do not include all the information needed to use BILDYOS safely and effectively. See full prescribing information for BILDYOS. BILDYOS ® (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILDYOS ® (denosumab-nxxp) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betw | Organon LLC | Shanghai Henlius Biotech, Inc. | Shanghai Henlius Biologics Co.,Ltd. | WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd. |
| 78206-193-01 | These highlights do not include all the information needed to use BILDYOS safely and effectively. See full prescribing information for BILDYOS. BILDYOS ® (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILDYOS ® (denosumab-nxxp) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betw | Organon LLC | Shanghai Henlius Biotech, Inc. | Shanghai Henlius Biologics Co.,Ltd. | WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd. |
| 78206-193-01 | These highlights do not include all the information needed to use BILDYOS safely and effectively. See full prescribing information for BILDYOS. BILDYOS ® (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILDYOS ® (denosumab-nxxp) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betw | Organon LLC | Shanghai Henlius Biotech, Inc. | Shanghai Henlius Biologics Co.,Ltd. | Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 | WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd. |
| 78206-195 | These highlights do not include all the information needed to use BILPREVDA safely and effectively. See full prescribing information for BILPREVDA. BILPREVDA ® (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILPREVDA ® (denosumab-nxxp) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differen | Organon LLC | Shanghai Henlius Biotech, Inc. | Shanghai Henlius Biologics Co.,Ltd. | WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd. |
| 78206-195 | These highlights do not include all the information needed to use BILPREVDA safely and effectively. See full prescribing information for BILPREVDA. BILPREVDA ® (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILPREVDA ® (denosumab-nxxp) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differen | Organon LLC | Shanghai Henlius Biotech, Inc. | Shanghai Henlius Biologics Co.,Ltd. | Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 | WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd. |
| 78206-195-01 | These highlights do not include all the information needed to use BILPREVDA safely and effectively. See full prescribing information for BILPREVDA. BILPREVDA ® (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILPREVDA ® (denosumab-nxxp) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differen | Organon LLC | Shanghai Henlius Biotech, Inc. | Shanghai Henlius Biologics Co.,Ltd. | WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd. |
| 78206-195-01 | These highlights do not include all the information needed to use BILPREVDA safely and effectively. See full prescribing information for BILPREVDA. BILPREVDA ® (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILPREVDA ® (denosumab-nxxp) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differen | Organon LLC | Shanghai Henlius Biotech, Inc. | Shanghai Henlius Biologics Co.,Ltd. | Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 | WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd. |
| 83257-029 | These highlights do not include all the information needed to use BOSAYA safely and effectively. See full prescribing information for BOSAYA. BOSAYA TM (denosumab-kyqq) injection, for subcutaneous use Initial U.S. Approval: 2025 BOSAYA TM (denosumab-kyqq) is biosimilar* to PROLIA ® (denosumab). | Biocon Biologics Inc. | Biocon Biologics Limited |
| 83257-029-41 | These highlights do not include all the information needed to use BOSAYA safely and effectively. See full prescribing information for BOSAYA. BOSAYA TM (denosumab-kyqq) injection, for subcutaneous use Initial U.S. Approval: 2025 BOSAYA TM (denosumab-kyqq) is biosimilar* to PROLIA ® (denosumab). | Biocon Biologics Inc. | Biocon Biologics Limited |
| 83257-030 | These highlights do not include all the information needed to use AUKELSO safely and effectively. See full prescribing information for AUKELSO. AUKELSO TM (denosumab-kyqq) injection, for subcutaneous use Initial U.S. Approval: 2025 AUKELSO TM (denosumab-kyqq) is biosimilar* to XGEVA ® (denosumab). | Biocon Biologics Inc. | Biocon Biologics Limited |
| 83257-030-11 | These highlights do not include all the information needed to use AUKELSO safely and effectively. See full prescribing information for AUKELSO. AUKELSO TM (denosumab-kyqq) injection, for subcutaneous use Initial U.S. Approval: 2025 AUKELSO TM (denosumab-kyqq) is biosimilar* to XGEVA ® (denosumab). | Biocon Biologics Inc. | Biocon Biologics Limited |
| 83457-012 | These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV. OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Initial U.S. Approval: 2025 OSPOMYV (denosumab-dssb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between | Cordavis Limited | Samsung Bioepis Co., Ltd. | Samsung Biologics Co., Ltd. | FARMACEUTICI FORMENTI SPA |
| 83457-012-10 | These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV. OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Initial U.S. Approval: 2025 OSPOMYV (denosumab-dssb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between | Cordavis Limited | Samsung Bioepis Co., Ltd. | Samsung Biologics Co., Ltd. | FARMACEUTICI FORMENTI SPA |