Shanghai Henlius Biotech and Organon have received approval from the US Food and Drug Administration (FDA) for BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), biosimilars to Prolia and Xgeva.

上海复宏汉霖生物技术有限公司和奥尔贡公司已获得美国食品和药物管理局 (FDA) 批准 BILDYOS®（地诺单抗-nxxp）和 BILPREVDA®（地诺单抗-nxxp），分别是 Prolia 和 Xgeva 的生物类似药。

BILDYOS, supplied as a 60 mg/mL injection, is indicated for the treatment of postmenopausal women and men with osteoporosis at high risk of fracture, patients with glucocorticoid-induced osteoporosis, and individuals receiving therapies that increase fracture risk, such as androgen deprivation therapy for prostate cancer or aromatase inhibitor therapy for breast cancer..

BILDYOS，作为一种60毫克/毫升的注射剂，适用于治疗绝经后妇女和骨折高风险的骨质疏松症男性患者、糖皮质激素诱发的骨质疏松症患者，以及接受增加骨折风险疗法的个体，例如前列腺癌的雄激素剥夺疗法或乳腺癌的芳香化酶抑制剂疗法。

The approvals cover all existing indications of the reference medicines, expanding treatment options for patients in the United States.

这些批准涵盖了参考药物的所有现有适应症，为美国患者扩大了治疗选择。

BILDYOS, supplied as a 60 mg/mL injection, is indicated for the treatment of postmenopausal women and men with osteoporosis at high risk of fracture, patients with glucocorticoid-induced osteoporosis, and individuals receiving therapies that increase fracture risk, such as androgen deprivation therapy for prostate cancer or aromatase inhibitor therapy for breast cancer..

BILDYOS，作为一种60毫克/毫升的注射剂，适用于治疗骨折高风险的绝经后妇女和男性骨质疏松症患者、糖皮质激素诱发的骨质疏松症患者，以及接受增加骨折风险治疗的个体，例如前列腺癌的雄激素剥夺疗法或乳腺癌的芳香化酶抑制剂疗法。

BILPREVDA, supplied as a 120 mg/1.7 mL injection, is indicated for the prevention of skeletal-related events in certain patients with multiple myeloma and bone metastases from solid tumours. It is also approved for use in patients with giant cell tumour of bone and hypercalcaemia of malignancy.

BILPREVDA，作为一种120毫克/1.7毫升的注射剂，适用于预防多发性骨髓瘤和实体瘤骨转移患者的骨骼相关事件。它也被批准用于骨巨细胞瘤和恶性高钙血症患者。

The approvals were supported by a comprehensive data package including structural, functional, and pharmacokinetic studies, as well as comparative clinical trials. These showed that the biosimilars are highly similar to their reference medicines, with no clinically meaningful differences in terms of safety, purity, or potency..

这些批准得到了一个综合数据包的支持，其中包括结构、功能和药代动力学研究，以及比较性临床试验。这些数据表明，这些生物类似药与其参照药物高度相似，在安全性、纯度或效力方面没有临床上的显著差异。

Both products carry important safety considerations. Patients with advanced kidney disease receiving BILDYOS face a higher risk of severe hypocalcaemia and should be evaluated for chronic kidney disease-mineral bone disorder before starting treatment. In the case of BILPREVDA, risks include severe hypocalcaemia, hypersensitivity reactions, osteonecrosis of the jaw, and foetal harm.

这两种产品都有重要的安全考虑。接受BILDYOS治疗的晚期肾病患者面临严重低钙血症的更高风险，在开始治疗前应评估慢性肾病-矿物质骨病。对于BILPREVDA，风险包括严重低钙血症、过敏反应、颌骨骨坏死和胎儿伤害。

Patients should be monitored carefully during therapy, with calcium and vitamin D supplementation recommended..

患者在治疗期间应仔细监测，并建议补充钙和维生素D。

Henlius and Organon have been working together under a licence and supply agreement signed in 2022, which granted Organon exclusive rights to commercialise BILDYOS and BILPREVDA outside China.

复宏汉霖与欧加农根据双方在2022年签署的许可和供货协议开展合作，该协议授予欧加农在中国以外地区商业化BILDYOS和BILPREVDA的独家权利。

The two companies highlighted that the approvals expand treatment options for patients in the US while contributing to broader access to biologic therapies.

这两家公司强调，这些批准为美国患者扩展了治疗选择，同时有助于更广泛地获得生物疗法。

Source: henlius.com

来源：henlius.com