US Food and Drug Administration (FDA) Approves Henlius and Organon's BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively
Tuesday, 2 September 2025 ()
SHANGHAI and JERSEY CITY, N.J., Sept. 2, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (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.^1,2
"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.^3,4,5 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.^3,4 "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."^4,5,6
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. *See full indications below. *
Hypersensitivity reactions, including anaphylaxis, may occur with use of denosumab products, including BILPREVDA. Discontinue permanently if a clinically significant reaction occurs. Denosumab products can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct hypocalcemia prior to initiating BILPREVDA. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting BILPREVDA. Monitor for symptoms. Avoid invasive dental procedures during treatment. Evaluate patients with thigh or groin pain to rule out a femoral fracture. When BILPREVDA treatment is discontinued, evaluate the individual patient's risk for vertebral fractures. BILPREVDA can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception. *See additional safety information below.*
"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.^8,9
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.^10
"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.^4,5,8 "Together, we are working to broaden access to important treatment options and better meet the needs of both patients and providers in the US."^5
BILDYOS and BILPREVDA join Organon's biosimilars portfolio in the US, which has been growing for over eight years and spans five major therapeutic areas.^11-14 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.^5,7,8
*About BILDYOS^® (denosumab-nxxp)*
*BILDYOS is a RANK ligand (RANKL) inhibitor indicated for/to:*
· *Postmenopausal Women with Osteoporosis at High Risk for Fracture: *BILDYOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, BILDYOS reduces the incidence of vertebral, nonvertebral, and hip fractures.· *Increase Bone Mass in Men with Osteoporosis: *BILDYOS is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.· *Glucocorticoid-Induced Osteoporosis: *BILDYOS is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.· *Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer: *BILDYOS is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients, denosumab products also reduced the incidence of vertebral fractures.· *Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer: *BILDYOS is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
*SELECTED SAFETY INFORMATION*
*SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
Patients with advanced chronic kidney disease (eGFR
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