Organon and Henlius receive US FDA approval for denosumab biosimilars

Organon and Henlius announced the US FDA approval of their denosumab biosimilars. Organon is a global healthcare company developing and delivering health solutions through prescription therapies and medical devices. Its portfolio includes contraception and fertility brands, biosimilars for immunology and oncology treatments, and established brands in various therapeutic areas. Henlius is a biopharmaceutical company focused on developing and commercializing biosimilar medicines. The approval of these biosimilars will expand treatment options for patients with immunology and oncology conditions.

The US Food and Drug Administration (FDA) has approved two denosumab biosimilars, BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), developed by Shanghai Henlius Biotech, Inc. and Organon (NYSE: OGN). These biosimilars are indicated for various bone health conditions, including osteoporosis and multiple myeloma.

BILDYOS is a RANK ligand (RANKL) inhibitor indicated for treating postmenopausal women with osteoporosis at high risk for fracture, increasing bone mass in men with osteoporosis, and managing glucocorticoid-induced osteoporosis and bone loss in men receiving androgen deprivation therapy for prostate cancer or women receiving adjuvant aromatase inhibitor therapy for breast cancer [1].

BILPREVDA, on the other hand, is indicated for preventing skeletal-related events in patients with multiple myeloma, bone metastases from solid tumors, giant cell tumor of bone, and hypercalcemia of malignancy [1].

The approval of these biosimilars marks a significant step in expanding access to critical bone care treatments in the US. The collaboration between Henlius and Organon aims to improve access and affordability across multiple therapeutic areas, including osteoporosis, which disproportionately affects women [1].

Henlius and Organon entered into a license and supply agreement in 2022, granting Organon exclusive commercialization rights to several biosimilars, including BILDYOS and BILPREVDA [1]. The agreement covers exclusive global commercialization rights except for China.

The approval of these biosimilars is a testament to the strong collaboration between Henlius and Organon to expand patient access to quality and potentially more affordable biosimilars [1]. This milestone reflects Organon’s long-standing commitment to expanding access to quality, cost-effective treatments and to advancing women’s health through a sustainable, patient-centered approach [1].

References:

[1] https://www.biospace.com/press-releases/us-food-and-drug-administration-fda-approves-henlius-and-organons-bildyos-denosumab-nxxp-and-bilprevda-denosumab-nxxp-biosimilars-to-prolia-denosumab-and-xgeva-denosumab-respectively