On 23 May 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the granting of a marketing authorization for three denosumab biosimilar medicines. The products are Fresenius Kabi’s Bomyntra and Conexxence and Sandoz’s Rolcya.
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 originator products are Amgen’s Prolia and Xgeva (denosumab). Prolia was approved by the EMA for the treatment of bone resorption and postmenopausal osteoporosis and Xgeva was approved for the treatment of bone fractures and neoplasm metastasis.
Bomyntra (denosumab) references Xgeva and is indicated for 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.
Conexxence (denosumab) references Prolia and is indicated for the treatment of osteoporosis, a disease that makes bones fragile, in postmenopausal women and in men at increased risk of fractures.
Rolcya (denosumab), also references Prolia and is indicated for the treatment of osteoporosis and bone loss.
This news comes after the CHMP adopted positive opinions for eight denosumab biosimilar medicines in April 2025. Those referencing Prolia included: Biosimilar Collaborations Ireland Limited’s Denosumab BBL (denosumab), Mabxience Research’s Izamby (denosumab), Gedeon Richter’s Junod (denosumab) and Zentiva’s Zadenvi (denosumab). And those referencing Xgeva were: Mabxience Research’s Denbrayce (denosumab), Zentiva’s Enwylma (denosumab), Biosimilar Collaborations Ireland Limited’s Vevzuo (denosumab) and Gedeon Richter’s Yaxwer (denosumab) [2].
By the end of May 2025, the EMA had recommended the granting of marketing authorization for a total of 19 denosumab biosimilars - nine referencing Xgeva and 10 referencing Prolia [3]. while the US Food and Drug Administration had approved only eight.
Of these 19 recommendations, six had already received the marketing authorization from the European Commission: Jubbonti, Obodence, and Stoboclo (referencing Prolia), and Osenvelt, Wyost, and Xbryk (referencing Xgeva).
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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 May 27]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. 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 May 27]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-nine-biosimilars-for-approval-including-trastuzumab-and-denosumab
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 27]. Available from:
www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
4. GaBI Online - Generics and Biosimilars Initiative. EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 27]. Available from: www.gabionline.net/biosimilars/news/ec-biosimilar-approvals-omlyclo-jubbonti-wyost-and-pyzchiva
5. GaBI Online - Generics and Biosimilars Initiative. EC approves eight biosimilars, six more await final authorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 27]. Available from: www.gabionline.net/biosimilars/news/ec-approves-eight-biosimilars-six-more-await-final-authorization
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