SHANGHAI, China – March 24, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that Health Canada has approved BILDYOS® (denosumab) injection 60 mg/mL and TUZEMTY® (denosumab, trade name: BILPREVDA® in the U.S. and Europe) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference product.

“The approvals in Canada mark another significant regulatory milestone of the products following prior approvals in the U.S., EU and the UK, as well as a key milestone in our collaboration with Organon,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “Together, we’ve translated our shared vision into tangible outcomes—bringing a new treatment option to patients in Canada and reinforcing our joint commitment to long-term access and value.”

BILDYOS (denosumab injection) has been approved for the treatment of osteoporosis in postmenopausal women at high risk of fracture, to increase bone mass in men with osteoporosis at high risk for fracture, the treatment and prevention of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer.

TUZEMTY (denosumab injection) has been approved for reducing the risk of developing skeletal-related events in patients with multiple myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumors; for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and for the treatment of hypercalcemia of malignancy that is refractory to intravenous bisphosphonate.

BILDYOS (denosumab injection) and TUZEMTY (denosumab injection) were approved based on the review of a comprehensive data package, which included structural and functional analytical data, nonclinical and clinical pharmacokinetic data, and a comparative clinical study demonstrating no clinically meaningful differences from reference products PROLIA and XGEVA in terms of safety, purity, and potency.

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS (denosumab injection) and TUZEMTY (denosumab injection). The agreement covers exclusive global commercialization rights except for China. BILDYOS (denosumab injection) and TUZEMTY (denosumab injection) are expected to be commercialized in Canada by Organon later this year.
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