On 28 February 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Stoboclo and Osenvelt (denosumab-bmwo), a denosumab biosimilar referencing Amgen’s Prolia and Xgeva respectively.
Amid a wave of denosumab biosimilar approvals, by the end of May 2025, the European Medicines Agency had recommended marketing authorization for 19 denosumab biosimilars (nine referencing Xgeva and 10 referencing Prolia) [3], while the FDA had approved only eight.
Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone [1].
The Stoboclo 60 mg/mL injection was approved by the FDA based on comprehensive data and clinical evidence confirming its therapeutic equivalence to Prolia. Stoboclo is approved to treat ‘postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer’.
The Osenvelt 120 mg/1.7 mL (70 mg/mL) injection was approved based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to Xgeva. Osenvelt is indicated to ‘prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours, to treat 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, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy’.
Stoboclo and Osenvelt have already been approved in Europe [2] and the US [3, 4], where it joins a host of other denosumab biosimilars [5, 6] and Australia [7].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 5]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA approved a record 28 biosimilars in 2024 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 5]. Available from: www.gabionline.net/reports/ema-approved-a-record-28-biosimilars-in-2024
3. GaBI Online - Generics and Biosimilars Initiative. Insulin aspart and denosumab biosimilars approved in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 5]. Available from: www.gabionline.net/biosimilars/news/insulin-aspart-and-denosumab-biosimilars-approved-in-us
4. GaBI Online - Generics and Biosimilars Initiative. FDA biosimilar approvals in March 2025: Bomyntra, Conexxence, and Omlyclo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 5]. Available from: www.gabionline.net/biosimilars/news/fda-biosimilar-approvals-in-march-2025-bomyntra-conexxence-and-omlyclo
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends nine biosimilars for approval including trastuzumab and denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 5]. Available from: https://gabionline.net/biosimilars/news/ema-recommends-nine-biosimilars-for-approval-including-trastuzumab-and-denosumab
6. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for three biosimilars: Jubereq, Osvyrti, and Qoyvolma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 5]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-three-biosimilars-jubereq-osvyrti-and-qoyvolma
7. GaBI Online - Generics and Biosimilars Initiative. Australia biosimilar approvals in early 2025 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 5]. Available from: www.gabionline.net/biosimilars/news/australia-biosimilar-approvals-in-early-2025
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