On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Sandoz’s medicinal products, Jubbonti and Wyost (denosumab), which are biosimilars of 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].
This marks the first approved biosimilar of Amgen’s Prolia and Xgeva in Europe and follows Sandoz’s first denosumab biosimilar, Jubbonti and Wyost, which was approved by Health Canada and the US Food and Drug Administration (FDA) in February and March 2024 [2].
Jubbonti is intended for the treatment of osteoporosis in women who have been through menopause and in men at increased risk of fractures whose bone loss is linked to hormone ablation or long-term treatment with systemic glucocorticoid. This will be available in Europe as 60 mg solution for injection in pre-filled syringe.
Wyost is intended for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone. This will be available as 120 mg solution for injection.
In the US, the products are approved as interchangeable biosimilars, which means they can be substituted for the reference products at the pharmacy level without requiring a pharmacist to obtain prescriber’s permission, subject to state pharmacy laws [3].
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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 2024 Apr 9]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. 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 2024 Apr 9]. Available from: www.gabionline.net/biosimilars/news/first-denosumab-biosimilars-approved-in-canada-and-the-us
3. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 9]. Available from:
www.gabionline.net/biosimilars/general/FDA-releases-new-information-on-interchangeable-biologicals
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