Marketing authorisations
EMA — authorised 17 May 2024
- Application: EMEA/H/C/006378
- Marketing authorisation holder: Sandoz GmbH
- Local brand name: Wyost
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 12 February 2025
- Application: EMEA/H/C/006424
- Marketing authorisation holder: Samsung Bioepis NL B.V.
- Local brand name: Obodence
- Indication: 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 sectio
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 12 February 2025
- Application: EMEA/H/C/006468
- Marketing authorisation holder: Samsung Bioepis NL B.V.
- Local brand name: Xbryk
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 14 February 2025
- Application: EMEA/H/C/006156
- Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
- Local brand name: Stoboclo
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 14 February 2025
- Application: EMEA/H/C/006157
- Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
- Local brand name: Osenvelt
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 26 May 2025
- Application: EMEA/H/C/006399
- Marketing authorisation holder: Accord Healthcare S.L.U.
- Local brand name: Osvyrti
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 26 May 2025
- Application: EMEA/H/C/006398
- Marketing authorisation holder: Accord Healthcare S.L.U.
- Local brand name: Jubereq
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 23 June 2025
- Application: EMEA/H/C/006437
- Marketing authorisation holder: Gedeon Richter Plc.
- Local brand name: Yaxwer
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 23 June 2025
- Application: EMEA/H/C/006436
- Marketing authorisation holder: Gedeon Richter Plc.
- Local brand name: Junod
- Indication: 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).
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 25 June 2025
- Application: EMEA/H/C/006534
- Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
- Local brand name: Vevzuo
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 26 June 2025
- Application: EMEA/H/C/006376
- Marketing authorisation holder: Zentiva k.s.
- Local brand name: Enwylma
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 26 June 2025
- Application: EMEA/H/C/006152
- Marketing authorisation holder: Mabxience Research SL
- Local brand name: Izamby
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 26 June 2025
- Application: EMEA/H/C/006199
- Marketing authorisation holder: Mabxience Research SL
- Local brand name: Denbrayce
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 26 June 2025
- Application: EMEA/H/C/006377
- Marketing authorisation holder: Zentiva k.s.
- Local brand name: Zadenvi
- Indication: 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
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 30 June 2025
- Application: EMEA/H/C/006526
- Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
- Local brand name: Evfraxy
- Indication: 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)
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 July 2025
- Application: EMEA/H/C/006507
- Marketing authorisation holder: Sandoz GmbH
- Local brand name: Rolcya
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 July 2025
- Application: EMEA/H/C/006269
- Marketing authorisation holder: Fresenius Kabi Deutschland GmbH
- Local brand name: Bomyntra
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 18 July 2025
- Application: EMEA/H/C/006268
- Marketing authorisation holder: Fresenius Kabi Deutschland GmbH
- Local brand name: Conexxence
- Indication: 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 sectio
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 September 2025
- Application: EMEA/H/C/006434
- Marketing authorisation holder: Sciencepharma Sp. z o.o
- Local brand name: Bildyos
- Indication: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. Inpostmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hipfractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased riskof fractures. In men with prostate cancer receiving hormone ablation, denosumabsignificantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients atincreased risk of fracture.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 September 2025
- Application: EMEA/H/C/006435
- Marketing authorisation holder: Sciencepharma Sp. z o.o
- Local brand name: Bilprevda
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 November 2025
- Application: EMEA/H/C/006797
- Marketing authorisation holder: Intas Third Party Sales 2005 S.L.
- Local brand name: Vysribli (previously Denosumab Intas)
- Indication: 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 sectio
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 November 2025
- Application: EMEA/H/C/006490
- Marketing authorisation holder: Stada Arzneimittel AG
- Local brand name: Kefdensis
- Indication: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Kefdensis 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, Kefdensis 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 sec
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 November 2025
- Application: EMEA/H/C/006239
- Marketing authorisation holder: Teva GmbH
- Local brand name: Degevma
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 November 2025
- Application: EMEA/H/C/006238
- Marketing authorisation holder: Teva GmbH
- Local brand name: Ponlimsi
- Indication: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Ponlimsi 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, Ponlimsi 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 November 2025
- Application: EMEA/H/C/006552
- Marketing authorisation holder: Stada Arzneimittel AG
- Local brand name: Zvogra
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 November 2025
- Application: EMEA/H/C/006722
- Marketing authorisation holder: Reddy Holding GmbH
- Local brand name: Xbonzy
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 17 November 2025
- Application: EMEA/H/C/006734
- Marketing authorisation holder: Reddy Holding GmbH
- Local brand name: Acvybra
- Indication: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Acvybra 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, Acvybra 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.
- Pathway: biosimilar
- Status: approved
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.
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EMA — authorised 8 January 2026
- Application: EMEA/H/C/006492
- Marketing authorisation holder: Theramex Ireland Limited
- Local brand name: Osqay
- Indication: 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.
- Pathway: biosimilar
- Status: approved
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.
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