On 27 March 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 biosimilar medicines: Accord’s Jubereq and Osvyrti (denosumab), and Celltrion’s Qoyvolma (ustekinumab).
Jubereq and Osvyrti (denosumab)
Accord’s Jubereq and Osvyrti (denosumab) are biosimilars referencing Amgen’s Xgeva and Prolia, respectively.
Jubereq 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.
Osvyrti is indicated for the treatment of osteoporosis in women who have been through menopause, in men with prostate cancer who are at increased risk of fractures and whose bone loss is linked to hormone ablation, and people whose bone loss is linked to long-term treatment with systemic glucocorticoids.
Jubereq and Osvyrti will be available as a 120 mg solution for injection, and Osvyrti will be available as a 60 mg solution for injection.
There are six denosumab biosimilars approved in Europe: Sandoz’s Jubbonti and Wyost [1], Samsung Bioepis’ Obodence and Xbryk [2], and Celltrion’s Osenvelt and Stoboclo [2].
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 [3].
Qoyvolma (ustekinumab)
Celltrion’s Qoyvolma is a biosimilar referencing Janssen/Johnson & Johnson’s Stelera (ustekinumab).
Qoyvolma is approved for the treatment of plaque psoriasis in adults and children, and treatment of psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults.
There are already eight other ustekinumab biosimilars approved in Europe: Formycon’s Fymskina, Accord Healthcare’s Imuldosa, Fresenius Kabi’s Otulfi, Samsung Bioepis’ Pyzchiva, Celltrion’s Steqeyma, Alvotech/Stada’s Uzpruvo, Amgen’s Wezenla, and Biocon’s Yesintek [4].
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References
1. 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 Apr 11]. Available from: www.gabionline.net/biosimilars/news/ec-biosimilar-approvals-omlyclo-jubbonti-wyost-and-pyzchiva
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for four denosumab biosimilars: Obodence, Osenvelt, Stoboclo, Xbryk [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 11]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-four-denosumab-biosimilars-obodence-osenvelt-stoboclo-xbryk
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 11]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
4. GaBI Online - Generics and Biosimilars Initiative. The ustekinumab shift: biosimilars displace Stelara’s market leadership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 11]. Available from: www.gabionline.net/biosimilars/general/the-ustekinumab-shift-biosimilars-displace-stelara-s-market-leadership
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