Shanghai Henlius Biotech and Organon announced the FDA has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.
"The FDA approvals of BILDYOS and BILPREVDA mark a significant step toward expanding access to critical bone care treatments needed by millions of people in the US, including a growing aging population. Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women," said Jon Martin, US Commercial Lead, Biosimilars and General Medicines at Organon. "This approval underscores Organon's unwavering commitment to making treatments more accessible while focusing on creating a more sustainable future for the care of bone health."
BILDYOS is a RANK ligand (RANKL) inhibitor indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at 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 breast cancer. See full indications below.
Patients with advanced kidney disease treated with BILDYOS are at greater risk of severe hypocalcemia. Severe hypocalcemia resulting in hospitalization, life-threatening events, and fatal cases have been reported with denosumab products. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. Prior to initiating BILDYOS in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with BILDYOS in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD. See additional safety information below.
BILPREVDA is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in certain patients with multiple myeloma and bone metastases from solid tumors, giant cell tumor of bone, and hypercalcemia of malignancy.
"The FDA approvals of BILDYOS and BILPREVDA mark another set of Henlius' self-developed and self-manufactured biosimilars approved in the United States, underscoring our commitment to scientific excellence and consistent product quality," said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. "We're proud to continue expanding access to quality biologics through the collaboration with Organon, delivering biosimilar treatment options that are as safe and effective as the reference biologics to more patients across the US."5,7,8
BILDYOS and BILPREVDA were approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and a comparative clinical study demonstrating that BILDYOS and BILPREVDA are highly similar to and have no clinically meaningful differences to their reference products, PROLIA and XGEVA, respectively, 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 and BILPREVDA. The agreement covers exclusive global commercialization rights except for China.
"These approvals are a testament to the strong collaboration between Henlius and Organon to expand patient access to quality and potentially more affordable biosimilars," said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. "Together, we are working to broaden access to important treatment options and better meet the needs of both patients and providers in the US."
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