{"id":"us-licensed-prolia-amgen","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"back pain"},{"rate":"10-20%","effect":"musculoskeletal pain"},{"rate":"5-10%","effect":"hypocalcemia"},{"rate":"5-10%","effect":"dizziness"},{"rate":"5-10%","effect":"nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By binding to RANKL, Prolia inhibits the formation of osteoclasts, which are cells responsible for bone breakdown. This leads to an increase in bone mass and a decrease in the risk of fractures. Prolia is administered via subcutaneous injection and has a half-life of approximately 28 days.","oneSentence":"Prolia is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:53:19.030Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of osteoporosis in postmenopausal women at high risk of fracture, treatment to increase bone mass in men with osteoporosis, treatment to increase bone mass in women with osteoporosis due to sustained systemic glucocorticoid therapy, treatment of bone loss associated with hormone ablation in men with prostate cancer, treatment of bone loss in women with breast cancer, treatment of giant cell tumor of bone, treatment of hypercalcemia of malignancy, treatment of multiple myeloma, treatment of bone metastases in men with prostate cancer, treatment of bone metastases in women with breast cancer"}]},"trialDetails":[{"nctId":"NCT04934072","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Fresenius Kabi SwissBioSim GmbH","startDate":"2021-06-16","conditions":"Postmenopausal Osteoporosis","enrollment":553}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Denosumab"],"phase":"phase_3","status":"active","brandName":"US-licensed Prolia (Amgen)","genericName":"US-licensed Prolia (Amgen)","companyName":"Fresenius Kabi SwissBioSim GmbH","companyId":"fresenius-kabi-swissbiosim-gmbh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"US-licensed Prolia (Amgen) is used to treat postmenopausal osteoporosis. It works by inhibiting interleukin-6, a protein involved in bone resorption.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2024-05-17T00:00:00.000Z","mah":"Sandoz GmbH","brand_name_local":"Wyost","application_number":"EMEA/H/C/006378"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-02-12T00:00:00.000Z","mah":"Samsung Bioepis NL B.V.","brand_name_local":"Xbryk","application_number":"EMEA/H/C/006468"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-02-12T00:00:00.000Z","mah":"Samsung Bioepis NL B.V.","brand_name_local":"Obodence","application_number":"EMEA/H/C/006424"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-02-14T00:00:00.000Z","mah":"Celltrion Healthcare Hungary Kft.","brand_name_local":"Stoboclo","application_number":"EMEA/H/C/006156"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-02-14T00:00:00.000Z","mah":"Celltrion Healthcare Hungary Kft.","brand_name_local":"Osenvelt","application_number":"EMEA/H/C/006157"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-05-26T00:00:00.000Z","mah":"Accord Healthcare S.L.U.","brand_name_local":"Jubereq","application_number":"EMEA/H/C/006398"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-05-26T00:00:00.000Z","mah":"Accord Healthcare S.L.U.","brand_name_local":"Osvyrti","application_number":"EMEA/H/C/006399"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-06-23T00:00:00.000Z","mah":"Gedeon Richter Plc.","brand_name_local":"Junod","application_number":"EMEA/H/C/006436"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-06-23T00:00:00.000Z","mah":"Gedeon Richter Plc.","brand_name_local":"Yaxwer","application_number":"EMEA/H/C/006437"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-06-25T00:00:00.000Z","mah":"Biosimilar Collaborations Ireland Limited","brand_name_local":"Vevzuo","application_number":"EMEA/H/C/006534"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-06-26T00:00:00.000Z","mah":"Zentiva k.s.","brand_name_local":"Enwylma","application_number":"EMEA/H/C/006376"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-06-26T00:00:00.000Z","mah":"Mabxience Research SL","brand_name_local":"Denbrayce","application_number":"EMEA/H/C/006199"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-06-26T00:00:00.000Z","mah":"Mabxience Research SL","brand_name_local":"Izamby","application_number":"EMEA/H/C/006152"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-06-26T00:00:00.000Z","mah":"Zentiva k.s.","brand_name_local":"Zadenvi","application_number":"EMEA/H/C/006377"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-06-30T00:00:00.000Z","mah":"Biosimilar Collaborations Ireland Limited","brand_name_local":"Evfraxy","application_number":"EMEA/H/C/006526"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-07-17T00:00:00.000Z","mah":"Fresenius Kabi Deutschland GmbH","brand_name_local":"Bomyntra","application_number":"EMEA/H/C/006269"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-07-17T00:00:00.000Z","mah":"Sandoz GmbH","brand_name_local":"Rolcya","application_number":"EMEA/H/C/006507"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-07-18T00:00:00.000Z","mah":"Fresenius Kabi Deutschland GmbH","brand_name_local":"Conexxence","application_number":"EMEA/H/C/006268"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-09-17T00:00:00.000Z","mah":"Sciencepharma Sp. z o.o","brand_name_local":"Bildyos","application_number":"EMEA/H/C/006434"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-09-17T00:00:00.000Z","mah":"Sciencepharma Sp. z o.o","brand_name_local":"Bilprevda","application_number":"EMEA/H/C/006435"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-11-17T00:00:00.000Z","mah":"Teva GmbH","brand_name_local":"Ponlimsi","application_number":"EMEA/H/C/006238"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-11-17T00:00:00.000Z","mah":"Reddy Holding GmbH","brand_name_local":"Xbonzy","application_number":"EMEA/H/C/006722"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-11-17T00:00:00.000Z","mah":"Stada Arzneimittel AG","brand_name_local":"Kefdensis","application_number":"EMEA/H/C/006490"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-11-17T00:00:00.000Z","mah":"Intas Third Party Sales 2005 S.L.","brand_name_local":"Vysribli (previously Denosumab Intas)","application_number":"EMEA/H/C/006797"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-11-17T00:00:00.000Z","mah":"Reddy Holding GmbH","brand_name_local":"Acvybra","application_number":"EMEA/H/C/006734"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-11-17T00:00:00.000Z","mah":"Teva GmbH","brand_name_local":"Degevma","application_number":"EMEA/H/C/006239"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-11-17T00:00:00.000Z","mah":"Stada Arzneimittel AG","brand_name_local":"Zvogra","application_number":"EMEA/H/C/006552"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2026-01-08T00:00:00.000Z","mah":"Theramex Ireland Limited","brand_name_local":"Osqay","application_number":"EMEA/H/C/006492"}],"regulatorySummaries":{"EU_EMA_approval_188097":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188097","summary_short":"EMA granted marketing authorisation for Osqay (denosumab), a biosimilar of Prolia, for the treatment of osteoporosis and bone loss in various patient populations.","summary_long":"On 8 January 2026, the European Medicines Agency (EMA) granted marketing authorisation for Osqay (denosumab), a biosimilar of Prolia, to Theramex Ireland Limited. Osqay is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It is also approved for the treatment of bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.","key_points":["Osqay (denosumab) is a biosimilar of Prolia approved for the treatment of osteoporosis and bone loss in various patient populations.","EMA granted marketing authorisation for Osqay on 8 January 2026, application number EMEA/H/C/006492."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/osqay"}],"generated_at":"2026-05-18T08:35:37.186Z"},"EU_EMA_approval_188307":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188307","summary_short":"The EMA granted marketing authorisation for Zvogra (US-licensed Prolia) on 17 November 2025 for prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) approved Zvogra, a biosimilar of Prolia (US-licensed), on 17 November 2025. This approval allows Stada Arzneimittel AG to market Zvogra in the European Union for two indications: prevention of skeletal related events in adults with advanced malignancies involving bone, and 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.","key_points":["EMA approved Zvogra (biosimilar of Prolia) on 17 November 2025.","Indications approved: prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","Marketing authorisation holder: Stada Arzneimittel AG.","Local brand name: Zvogra."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/zvogra"}],"generated_at":"2026-05-18T08:36:13.107Z"},"EU_EMA_approval_188087":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188087","summary_short":"The EMA granted marketing authorisation to Acvybra (biosimilar of Prolia) for the treatment of osteoporosis and bone loss in postmenopausal women, men with prostate cancer, and adults on long-term glucocorticoid therapy.","summary_long":"On 17 November 2025, the European Medicines Agency (EMA) granted marketing authorisation to Acvybra, a biosimilar of Prolia (US-licensed), for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Acvybra also received approval for the treatment of bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. The marketing authorisation holder is Reddy Holding GmbH, and the local brand name is Acvybra.","key_points":["Acvybra is a biosimilar of Prolia (US-licensed) for the treatment of osteoporosis and bone loss.","Approved indications include postmenopausal women, men with prostate cancer, and adults on long-term glucocorticoid therapy.","Marketing authorisation holder is Reddy Holding GmbH, and the local brand name is Acvybra."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/acvybra"}],"generated_at":"2026-05-18T08:36:13.884Z"},"EU_EMA_approval_187795":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"187795","summary_short":"EMA granted marketing authorisation for US-licensed Prolia (Amgen) biosimilar, Vysribli, on 17 November 2025.","summary_long":"The European Medicines Agency (EMA) approved Vysribli (previously Denosumab Intas), a biosimilar of Prolia (Amgen), on 17 November 2025. This approval allows Intas Third Party Sales 2005 S.L. to market Vysribli in the European Union for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Additionally, Vysribli is approved for the treatment of bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.","key_points":["EMA approved Vysribli (Denosumab Intas) on 17 November 2025.","Vysribli is a biosimilar of Prolia (Amgen) for the treatment of osteoporosis and bone loss in various patient populations.","Approved indications include postmenopausal women, men with prostate cancer, and adult patients on long-term glucocorticoid therapy."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/vysribli-previously-denosumab-intas"}],"generated_at":"2026-05-18T08:36:14.466Z"},"EU_EMA_approval_188267":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188267","summary_short":"EMA granted marketing authorisation for Degevma (biosimilar Prolia) on 17 November 2025 for preventing skeletal-related events in adults with advanced malignancies and treating giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) approved Degevma, a biosimilar version of Prolia (US-licensed Amgen), on 17 November 2025. This approval allows Teva GmbH to market Degevma in the European Union for two indications: prevention of skeletal-related events in adults with advanced malignancies involving bone, and 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. Degevma was approved through the biosimilar expedited pathway.","key_points":["Degevma is a biosimilar version of Prolia (US-licensed Amgen) approved in the European Union.","EMA approved Degevma on 17 November 2025 for two indications: prevention of skeletal-related events and treatment of giant cell tumour of bone.","Teva GmbH is the marketing authorisation holder for Degevma in the European Union."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/degevma"}],"generated_at":"2026-05-18T08:36:14.993Z"},"EU_EMA_approval_188025":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188025","summary_short":"EMA granted marketing authorisation for Kefdensis (biosimilar to Prolia) on 17 November 2025 for treating osteoporosis and bone loss in postmenopausal women, men with prostate cancer, and adults on glucocorticoid therapy.","summary_long":"The European Medicines Agency (EMA) granted marketing authorisation for Kefdensis, a biosimilar to Prolia (US-licensed Amgen), on 17 November 2025. Kefdensis is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It also treats bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adults at increased risk of fracture.","key_points":["Kefdensis is a biosimilar to Prolia (US-licensed Amgen) for treating osteoporosis and bone loss.","Indications include postmenopausal women, men with prostate cancer, and adults on glucocorticoid therapy.","Marketing authorisation granted by EMA on 17 November 2025."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/kefdensis"}],"generated_at":"2026-05-18T08:36:16.156Z"},"EU_EMA_approval_188258":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188258","summary_short":"EMA granted marketing authorisation for Ponlimsi (biosimilar to Prolia) on 17 November 2025 for treating osteoporosis and bone loss in postmenopausal women, men with prostate cancer, and adults on glucocorticoid therapy.","summary_long":"The European Medicines Agency (EMA) granted marketing authorisation for Ponlimsi, a biosimilar to Prolia (US-licensed Amgen product), on 17 November 2025. Ponlimsi is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It also treats bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. In postmenopausal women, Ponlimsi significantly reduces the risk of vertebral, non-vertebral, and hip fractures. In men with prostate cancer, it reduces the risk of vertebral fractures.","key_points":["Ponlimsi is a biosimilar to Prolia (US-licensed Amgen product)","Indicated for osteoporosis in postmenopausal women and men at increased risk of fractures","Treats bone loss in men with prostate cancer and adults on glucocorticoid therapy","Significantly reduces fracture risk in postmenopausal women and men with prostate cancer"],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/ponlimsi"}],"generated_at":"2026-05-18T08:36:17.357Z"},"EU_EMA_approval_187667":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"187667","summary_short":"The EMA granted marketing authorisation for Xbonzy (US-licensed Prolia) on 17 November 2025 for prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) approved Xbonzy, a biosimilar of Prolia (US-licensed), on 17 November 2025. Xbonzy is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone, such as pathological fracture, radiation to bone, spinal cord compression, or surgery to bone. Additionally, it is approved for the 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.","key_points":["Indication: Prevention of skeletal related events in adults with advanced malignancies involving bone, and treatment of giant cell tumour of bone.","Marketing authorisation holder: Reddy Holding GmbH","Local brand name: Xbonzy","Expedited pathway: Biosimilar","Approval date: 17 November 2025"],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/xbonzy"}],"generated_at":"2026-05-18T08:36:17.915Z"},"EU_EMA_approval_188323":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188323","summary_short":"EMA granted marketing authorisation for Bilprevda (US-licensed Prolia) on 17 September 2025 for prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) granted marketing authorisation for Bilprevda, a biosimilar of US-licensed Prolia (Amgen), on 17 September 2025. This authorisation allows for the use of Bilprevda in two indications: prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and 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. The marketing authorisation holder is Sciencepharma Sp. z o.o.","key_points":["EMA granted marketing authorisation for Bilprevda on 17 September 2025.","Indications approved: prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","Marketing authorisation holder: Sciencepharma Sp. z o.o.","Expedited pathway: biosimilar."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/bilprevda"}],"generated_at":"2026-05-18T08:36:52.681Z"},"EU_EMA_approval_188156":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188156","summary_short":"The EMA granted marketing authorisation for Bildyos (US-licensed Prolia, Amgen) on 17 September 2025 for the treatment of osteoporosis and bone loss in various patient groups.","summary_long":"The European Medicines Agency (EMA) approved Bildyos, a biosimilar of US-licensed Prolia (Amgen), on 17 September 2025. This approval allows Sciencepharma Sp. z o.o to market Bildyos in the European Union for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Additionally, Bildyos is approved for the treatment of bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.","key_points":["Bildyos is a biosimilar of US-licensed Prolia (Amgen) approved by the EMA on 17 September 2025.","The approved indications include osteoporosis in postmenopausal women and men at increased risk of fractures, bone loss in men with prostate cancer, and bone loss in adult patients on long-term systemic glucocorticoid therapy."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/bildyos"}],"generated_at":"2026-05-18T08:36:54.885Z"},"EU_EMA_approval_188471":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188471","summary_short":"EMA granted marketing authorisation to Sandoz GmbH's Rolcya (biosimilar Prolia) for treating osteoporosis and bone loss in postmenopausal women, men with prostate cancer, and adults on long-term glucocorticoid therapy.","summary_long":"On 17 July 2025, the European Medicines Agency (EMA) granted marketing authorisation to Sandoz GmbH's Rolcya, a biosimilar version of Amgen's Prolia. Rolcya is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It also treats bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adults at increased risk of fracture. Clinical trials demonstrated that Rolcya significantly reduces the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women, and vertebral fractures in men with prostate cancer.","key_points":["Rolcya (biosimilar Prolia) granted marketing authorisation by EMA on 17 July 2025.","Indicated for treating osteoporosis, bone loss in men with prostate cancer, and adults on long-term glucocorticoid therapy.","Significantly reduces risk of vertebral, non-vertebral, and hip fractures in postmenopausal women, and vertebral fractures in men with prostate cancer."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/rolcya"}],"generated_at":"2026-05-18T08:38:33.980Z"},"EU_EMA_approval_188066":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188066","summary_short":"EMA granted marketing authorisation to Conexxence (biosimilar Prolia) for treating osteoporosis and bone loss in postmenopausal women, men with prostate cancer, and adults on long-term glucocorticoid therapy.","summary_long":"On 18 July 2025, the European Medicines Agency (EMA) granted marketing authorisation to Fresenius Kabi Deutschland GmbH for Conexxence, a biosimilar version of Prolia (denosumab). Conexxence is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It also treats bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adults at increased risk of fracture. Clinical trials demonstrated that denosumab significantly reduces the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women, and vertebral fractures in men with prostate cancer.","key_points":["Conexxence is a biosimilar version of Prolia (denosumab) for treating osteoporosis and bone loss.","Indications include postmenopausal women, men with prostate cancer, and adults on long-term glucocorticoid therapy.","Clinical trials showed significant reduction in fracture risk in postmenopausal women and men with prostate cancer."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/conexxence"}],"generated_at":"2026-05-18T08:38:04.830Z"},"EU_EMA_approval_188681":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188681","summary_short":"The EMA granted marketing authorisation for Bomyntra (US-licensed Prolia) on 17 July 2025 for prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) approved Bomyntra, a biosimilar of Prolia (US-licensed), on 17 July 2025. This approval is for the prevention of skeletal-related events in adults with advanced malignancies involving bone. This includes pathological fractures, radiation to bone, spinal cord compression, or surgery to bone. Additionally, Bomyntra is approved for the 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. Fresenius Kabi Deutschland GmbH is the marketing authorisation holder for Bomyntra in the European Union.","key_points":["Bomyntra is a biosimilar of US-licensed Prolia (Amgen) approved by the EMA on 17 July 2025.","Indications approved: prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","Marketing authorisation holder: Fresenius Kabi Deutschland GmbH."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/bomyntra"}],"generated_at":"2026-05-18T08:38:36.465Z"},"EU_EMA_approval_187955":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"187955","summary_short":"The EMA granted marketing authorisation to Evfraxy (biosimilar of Prolia) for the treatment of osteoporosis and bone loss in various patient populations.","summary_long":"On 30 June 2025, the European Medicines Agency (EMA) granted marketing authorisation to Evfraxy, a biosimilar of Prolia (US-licensed), for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Evfraxy also received approval for the treatment of bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. This approval was granted under the biosimilar expedited pathway.","key_points":["Evfraxy is a biosimilar of Prolia (US-licensed) for the treatment of osteoporosis and bone loss.","Approved indications include postmenopausal women, men with prostate cancer, and adult patients on long-term systemic glucocorticoid therapy.","Marketing authorisation was granted on 30 June 2025 under the biosimilar expedited pathway."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/evfraxy"}],"generated_at":"2026-05-18T08:38:37.198Z"},"EU_EMA_approval_188353":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188353","summary_short":"The EMA granted marketing authorisation for Junod (biosimilar to Prolia) on 23 June 2025 for the treatment of osteoporosis and bone loss in various patient groups.","summary_long":"The European Medicines Agency (EMA) approved Junod, a biosimilar to Prolia (Amgen), on 23 June 2025. Junod is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It also treats bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.","key_points":["Junod is a biosimilar to Prolia (Amgen) approved by the EMA on 23 June 2025.","Indications include osteoporosis in postmenopausal women and men, bone loss in men with prostate cancer, and bone loss due to glucocorticoid therapy.","Marketing authorisation holder is Gedeon Richter Plc. with the local brand name Junod."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/junod"}],"generated_at":"2026-05-18T08:39:14.608Z"},"EU_EMA_approval_187684":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"187684","summary_short":"The EMA has granted marketing authorisation to Denbrayce (biosimilar to Prolia) for preventing skeletal-related events in adults with advanced malignancies and treating giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) has approved Denbrayce, a biosimilar to Prolia (US-licensed), for marketing in the European Union. This approval was granted on 26 June 2025, under the biosimilar expedited pathway. Denbrayce is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone, such as pathological fractures, radiation to bone, spinal cord compression, or surgery to bone. Additionally, it is approved for the 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.","key_points":["Denbrayce is a biosimilar to Prolia (US-licensed) approved for marketing in the European Union.","Indications: prevention of skeletal-related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","Approval date: 26 June 2025, under the biosimilar expedited pathway."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/denbrayce"}],"generated_at":"2026-05-18T08:38:39.908Z"},"EU_EMA_approval_188453":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188453","summary_short":"EMA granted marketing authorisation for Izamby (biosimilar to Prolia) on 26 June 2025 for treating osteoporosis and bone loss in postmenopausal women, men with prostate cancer, and adults on glucocorticoid therapy.","summary_long":"The European Medicines Agency (EMA) granted marketing authorisation for Izamby, a biosimilar to Prolia (denosumab), on 26 June 2025. Izamby is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It also treats bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. Studies have shown that Izamby significantly reduces the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women, and vertebral fractures in men with prostate cancer.","key_points":["Izamby is a biosimilar to Prolia (denosumab) for treating osteoporosis and bone loss.","Indications include postmenopausal women, men with prostate cancer, and adults on glucocorticoid therapy.","EMA granted marketing authorisation on 26 June 2025."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/izamby"}],"generated_at":"2026-05-18T08:39:11.818Z"},"EU_EMA_approval_188630":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188630","summary_short":"The EMA granted marketing authorisation for Zadenvi (biosimilar of Prolia) on 26 June 2025 for the treatment of osteoporosis and bone loss in various patient populations.","summary_long":"The European Medicines Agency (EMA) approved Zadenvi, a biosimilar of Prolia (denosumab), on 26 June 2025. Zadenvi is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It also treats bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.","key_points":["Zadenvi is a biosimilar of Prolia (denosumab) approved by the EMA on 26 June 2025.","Indications include osteoporosis in postmenopausal women and men at increased risk of fractures, bone loss in men with prostate cancer, and bone loss due to glucocorticoid therapy.","Marketing authorisation holder is Zentiva k.s. and the local brand name is Zadenvi."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/zadenvi"}],"generated_at":"2026-05-18T08:39:12.390Z"},"EU_EMA_approval_187841":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"187841","summary_short":"The EMA granted marketing authorisation for Enwylma (biosimilar Prolia) on 26 June 2025, for prevention of skeletal-related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) approved Enwylma, a biosimilar version of Prolia (US-licensed), on 26 June 2025. Enwylma is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. This includes pathological fractures, radiation to bone, spinal cord compression, or surgery to bone. Additionally, Enwylma is approved for the 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.","key_points":["Enwylma is a biosimilar version of Prolia (US-licensed) approved by the EMA on 26 June 2025.","Indications include prevention of skeletal-related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","Marketing authorisation holder is Zentiva k.s. and the local brand name is Enwylma."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/enwylma"}],"generated_at":"2026-05-18T08:39:12.940Z"},"EU_EMA_approval_187910":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"187910","summary_short":"The EMA granted marketing authorisation for Vevzuo (biosimilar Prolia) on 25 June 2025 for the prevention of skeletal-related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) approved Vevzuo, a biosimilar version of Prolia, on 25 June 2025. This approval allows Vevzuo to be used in the European Union for two indications: the prevention of skeletal-related events in adults with advanced malignancies involving bone, and the 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 is manufactured by Biosimilar Collaborations Ireland Limited and will be marketed under the local brand name Vevzuo.","key_points":["EMA approved Vevzuo (biosimilar Prolia) on 25 June 2025.","Indications: prevention of skeletal-related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","Manufacturer: Biosimilar Collaborations Ireland Limited, local brand name: Vevzuo."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/vevzuo"}],"generated_at":"2026-05-18T08:39:13.451Z"},"EU_EMA_approval_188702":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188702","summary_short":"The EMA granted marketing authorisation for Yaxwer (biosimilar Prolia) on 23 June 2025 for preventing skeletal-related events in adults with advanced malignancies and treating giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) approved Yaxwer, a biosimilar version of Prolia, on 23 June 2025. Yaxwer is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. This includes pathological fractures, radiation to bone, spinal cord compression, or surgery to bone. Additionally, Yaxwer is approved for the 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.","key_points":["Yaxwer is a biosimilar version of Prolia, approved for preventing skeletal-related events in adults with advanced malignancies and treating giant cell tumour of bone.","Marketing authorisation was granted on 23 June 2025, with Gedeon Richter Plc. as the marketing authorisation holder."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/yaxwer"}],"generated_at":"2026-05-18T08:39:14.084Z"},"EU_EMA_approval_188757":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188757","summary_short":"The EMA granted marketing authorisation for Jubereq (Prolia biosimilar) on 26 May 2025 for prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) approved Jubereq, a biosimilar of Prolia (US-licensed), on 26 May 2025. Jubereq is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. This includes pathological fractures, radiation to bone, spinal cord compression, or surgery to bone. Additionally, Jubereq is approved for the 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.","key_points":["Jubereq is a biosimilar of Prolia (US-licensed) approved by the EMA on 26 May 2025.","Indications include prevention of skeletal-related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","Marketing authorisation holder is Accord Healthcare S.L.U. and the local brand name is Jubereq."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/jubereq"}],"generated_at":"2026-05-18T08:39:51.192Z"},"EU_EMA_approval_188183":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188183","summary_short":"EMA granted marketing authorisation for Osvyrti (biosimilar Prolia) on 26 May 2025 for treating osteoporosis and bone loss in postmenopausal women, men with prostate cancer, and adults on glucocorticoid therapy.","summary_long":"The European Medicines Agency (EMA) granted marketing authorisation for Osvyrti, a biosimilar version of Prolia (denosumab), on 26 May 2025. Osvyrti is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It also treats bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. Clinical trials demonstrated that denosumab significantly reduces the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women, and vertebral fractures in men with prostate cancer.","key_points":["Osvyrti is a biosimilar version of Prolia (denosumab) approved by EMA on 26 May 2025.","Indications include osteoporosis in postmenopausal women and men at increased risk of fractures, bone loss in men with prostate cancer, and long-term glucocorticoid therapy in adults at increased risk of fracture."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/osvyrti"}],"generated_at":"2026-05-18T08:39:51.925Z"},"EU_EMA_approval_187960":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"187960","summary_short":"EMA granted marketing authorisation for Osenvelt (biosimilar Prolia) on 14 February 2025 for prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) granted marketing authorisation for Osenvelt, a biosimilar version of Prolia (denosumab), on 14 February 2025. This authorisation allows Osenvelt to be used for the prevention of skeletal-related events in adults with advanced malignancies involving bone, such as pathological fractures, radiation to bone, spinal cord compression, or surgery to bone. Additionally, Osenvelt is approved for the 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.","key_points":["EMA granted marketing authorisation for Osenvelt (biosimilar Prolia) on 14 February 2025.","Osenvelt is approved for prevention of skeletal-related events in adults with advanced malignancies involving bone.","Osenvelt is approved for treatment of giant cell tumour of bone in adults and skeletally mature adolescents."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/osenvelt"}],"generated_at":"2026-05-18T08:41:08.832Z"},"EU_EMA_approval_188309":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188309","summary_short":"The EMA granted marketing authorisation for Stoboclo (denosumab biosimilar), a treatment for osteoporosis and bone loss in postmenopausal women, men with prostate cancer, and adults on long-term glucocorticoid therapy, on 14 February 2025.","summary_long":"The European Medicines Agency (EMA) approved Stoboclo, a denosumab biosimilar, for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It also approved Stoboclo for the treatment of bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. This approval was granted on 14 February 2025, under the biosimilar expedited pathway.","key_points":["Stoboclo is a denosumab biosimilar approved for osteoporosis treatment in postmenopausal women and men at increased risk of fractures.","It is also approved for bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/stoboclo"}],"generated_at":"2026-05-18T08:41:42.457Z"},"EU_EMA_approval_188342":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188342","summary_short":"The EMA granted marketing authorisation for Obodence (biosimilar Prolia) on 12 February 2025, for the treatment of osteoporosis and bone loss in postmenopausal women, men with prostate cancer, and adults on long-term glucocorticoid therapy.","summary_long":"The European Medicines Agency (EMA) approved Obodence, a biosimilar version of Prolia, on 12 February 2025. This approval allows Samsung Bioepis NL B.V. to market Obodence in the European Union for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Additionally, Obodence is approved for the treatment of bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adults at increased risk of fracture.","key_points":["Obodence is a biosimilar version of Prolia, approved for the treatment of osteoporosis and bone loss in various patient populations.","The EMA approved Obodence on 12 February 2025, for marketing authorisation in the European Union."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/obodence"}],"generated_at":"2026-05-18T08:41:43.692Z"},"EU_EMA_approval_188792":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188792","summary_short":"The EMA granted marketing authorisation for Xbryk (biosimilar Prolia) on 12 February 2025 for prevention of skeletal-related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) approved Xbryk, a biosimilar version of Prolia, on 12 February 2025. Xbryk is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. This includes pathological fractures, radiation to bone, spinal cord compression, or surgery to bone. Additionally, Xbryk is approved for the 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. The marketing authorisation holder is Samsung Bioepis NL B.V.","key_points":["Xbryk is a biosimilar version of Prolia approved by the EMA on 12 February 2025.","Indications include prevention of skeletal-related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","Marketing authorisation holder is Samsung Bioepis NL B.V."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/xbryk"}],"generated_at":"2026-05-18T08:42:16.741Z"},"EU_EMA_approval_188732":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188732","summary_short":"EMA granted marketing authorisation for Wyost (biosimilar Prolia) on 17 May 2024 for prevention of skeletal related events in adults with advanced malignancies and treatment of giant cell tumour of bone.","summary_long":"The European Medicines Agency (EMA) granted marketing authorisation for Wyost, a biosimilar version of Prolia (denosumab), on 17 May 2024. Wyost is indicated for the prevention of skeletal related events (SREs) in adults with advanced malignancies involving bone. This includes pathological fracture, radiation to bone, spinal cord compression, or surgery to bone. Additionally, Wyost is approved for the 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.","key_points":["Wyost is a biosimilar version of Prolia (denosumab) approved by EMA on 17 May 2024.","Indications: prevention of SREs in adults with advanced malignancies and treatment of giant cell tumour of bone.","Marketing authorisation holder: Sandoz GmbH, local brand name: Wyost."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/wyost"}],"generated_at":"2026-05-18T09:20:05.177Z"}},"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}