On 14 November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Samsung Bioepis’ Obodence™ (SB16/denosumab) and Xbryk™ (SB16/denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively.
Obodence™ is recommended for approval for the treatment of osteoporosis in postmenopausal women, bone loss linked to hormone ablation in men at increased risk of fractures, and bone loss associated with long-term treatment with systemic glucocorticoid therapy.
Xbryk™ is recommended for approval 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.
Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilars to be approved in Europe in May 2024. The EMA has accepted MAAs for denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius Biotech/Organon (HLX14, May 2024).
On 5 November 2024, the Australian Register of Therapeutic Goods (ARTG), approved 5 supplemental brands for Amgen’s denosumab (Ganvado™, Zerount™, Corora™, Rexadev™ and Deptargis™), none of which have been approved elsewhere to date.