The US Food and Drug Administration has approved two denosumab biosimilars developed by Shanghai Henlius Biotech and commercialized by Organon, marking a significant expansion in treatment options for bone health conditions affecting millions of Americans.
BILDYOS (denosumab-nxxp) injection 60 mg/mL and BILPREVDA (denosumab-nxxp) injection 120 mg/1.7 mL received FDA approval as biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.
Expanding Access to Critical Bone Care
"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," said Jon Martin, US Commercial Lead, Biosimilars and General Medicines at Organon. "Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women."
The approvals address substantial unmet medical needs in bone health, particularly for osteoporosis treatment in postmenopausal women and cancer-related bone complications.
BILDYOS: Comprehensive Osteoporosis Treatment
BILDYOS, a RANK ligand (RANKL) inhibitor, is indicated for multiple bone health conditions:
- Treatment of postmenopausal women with osteoporosis at high risk for fracture
- Increasing bone mass in men with osteoporosis at high fracture risk
- Treatment of glucocorticoid-induced osteoporosis in men and women at high fracture risk
- Increasing bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer
- Increasing bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer
In postmenopausal women with osteoporosis, BILDYOS reduces the incidence of vertebral, nonvertebral, and hip fractures. The drug also demonstrated efficacy in reducing vertebral fractures in men receiving androgen deprivation therapy.
BILPREVDA: Targeting Cancer-Related Bone Disease
BILPREVDA, also a RANKL inhibitor, addresses cancer-related bone complications with indications for:
- Prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors
- Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection would result in severe morbidity
- Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy
Rigorous Development and Safety Profile
The FDA approvals were based on a comprehensive data package including structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies. These studies demonstrated that BILDYOS and BILPREVDA are highly similar to their reference products with no clinically meaningful differences in terms of safety, purity, and potency.
Both products carry important safety considerations. BILDYOS includes a boxed warning for severe hypocalcemia in patients with advanced kidney disease, with patients having chronic kidney disease requiring supervision by healthcare providers with CKD-MBD expertise. Common adverse reactions for BILDYOS in postmenopausal women include back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.
BILPREVDA's safety profile includes warnings for hypocalcemia, osteonecrosis of the jaw, and atypical femoral fractures. The most common adverse reactions vary by indication, with fatigue, hypophosphatemia, and nausea being frequent in patients with bone metastases from solid tumors.
Strategic Partnership and Market Impact
The approvals stem from a 2022 license and supply agreement between Henlius and Organon, granting Organon exclusive global commercialization rights except for China. "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.
BILDYOS and BILPREVDA join Organon's growing biosimilars portfolio in the US, which has been expanding for over eight years across five major therapeutic areas. This milestone reflects Organon's commitment to expanding access to quality, cost-effective treatments while advancing women's health through sustainable, patient-centered approaches.
Clinical Significance and Future Outlook
The approvals represent a significant advancement in bone health treatment accessibility. With these approvals, Henlius now has six products approved for marketing in overseas markets, demonstrating the company's successful expansion into global markets with self-developed biosimilars.
"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."
The introduction of these biosimilars is expected to provide healthcare providers and patients with additional treatment options while potentially reducing costs associated with bone health management, particularly important given the growing aging population and increasing prevalence of osteoporosis and cancer-related bone complications.
