The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the granting of marketing authorization for four denosumab biosimilars: Obodence and Xbryk (SB16), developed by Samsung Bioepis, on 14 November 2024, and Stoboclo and Osenvelt (CT-P41), developed by Celltrion, on 12 December 2024. These biosimilars are based on Amgen’s reference products Prolia and Xgeva, respectively.
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].
Obodence has been recommended for approval for the treatment of osteoporosis and bone loss.
Xbryk has been recommended for approval for the prevention of skeletal related events in adults with advanced malignancies involving bone, and the treatment of giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Obodence, referencing Prolia, will be available in a 60 mg pre-filled syringe, while Xbryk, referencing Xgeva, will be available in 120 mg vial.
The CHMP’s positive opinion of SB16 was based on a totality of evidence, including analytical, non-clinical, and clinical data. A Phase 1 study showed PK equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced denosumab (US-DEN) in healthy male participants, meeting primary PK endpoints. A Phase 3 study in postmenopausal osteoporosis (PMO) patients demonstrated equivalent efficacy and comparable safety, immunogenicity, PK, and PD profiles between SB16 and reference denosumab (DEN). The primary endpoint, percent change in lumbar spine bone mineral density (BMD) at Month 12, was met, with comparable results through Month 18 in terms of efficacy, PK, PD, safety and immunogenicity.
Stoboclo and Osenvelt have been recommended for approval for all indications of the reference products Prolia and Xgeva, respectively, including osteoporosis in postmenopausal women.
Stoboclo will be available as 60 mg solution for injection in pre-filled syringe, and Osenvelt will be available as 120 mg solution for injection.
The positive CHMP opinion of CT-P41 was based on the totality of evidence, including results from a Phase III clinical trial in postmenopausal osteoporosis. The results showed that CT-P41 had equivalent efficacy and pharmacodynamics to reference denosumab, with similar pharmacokinetics and comparable safety and immunogenicity profiles.
In May 2024, the European Commission (EC) approved two denosumab biosimilars: Sandoz’s Jubbonti and Wyost [2], which were also approved in Canada and the US in early 2024 [3],
If the EC grants marketing authorization, Obodence and Xbryk will become Samsung Bioepis’ first endocrinology biosimilars approved in Europe.
Celltrion’s denosumab biosimilars also received approval from South Korea’s Ministry of Food and Drug Safety on 22 November 2024. These include Stavoklone, a biosimilar of Prolia, and Osenvilt, a biosimilar of 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 Jan 15]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. 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 Jan 15]. Available from: www.gabionline.net/biosimilars/news/ec-biosimilar-approvals-omlyclo-jubbonti-wyost-and-pyzchiva
3. GaBI Online - Generics and Biosimilars Initiative. First denosumab biosimilars approved in Canada and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 15]. Available from: www.gabionline.net/biosimilars/news/first-denosumab-biosimilars-approved-in-canada-and-the-us
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