Breakthrough Clinical Results
The US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), biosimilars to PROLIA and XGEVA, respectively. Developed by Henlius and commercialized by Organon, these biosimilars are approved for all indications of the reference products. BILDYOS is indicated for various osteoporosis treatments, while BILPREVDA targets skeletal-related events in multiple myeloma and bone metastases. The approvals highlight a commitment to expanding access to affordable bone care treatments and underscore the successful collaboration between Henlius and Organon.
Key Highlights
- FDA approval of BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp) biosimilars.
- Approved for all indications of the reference products PROLIA and XGEVA.
- Expansion of access to affordable bone care treatments in the US.
- Successful collaboration between Henlius and Organon.
Drug used in other indications
Denosumab-nxxp Clinical Trials Beyond Osteoporosis
After a comprehensive review of available information, there is insufficient data regarding clinical trials of denosumab-nxxp for indications other than osteoporosis. The current literature does not specifically document any trials investigating this biosimilar version of denosumab for alternative therapeutic applications.
Denosumab itself (marketed as Xgeva and Prolia) has established uses in treating conditions such as bone metastases and preventing skeletal-related events in cancer patients, in addition to its primary indication for osteoporosis. However, specific information about denosumab-nxxp being investigated for these or other non-osteoporotic conditions is not currently documented.
Regarding intervention models for potential trials of denosumab-nxxp beyond osteoporosis applications, no specific information is available about the trial designs, dosing protocols, comparison groups, or methodological approaches that might be employed in such investigations.
The development of biosimilar medications typically follows the established indications of the original product, but specific details about expanded applications of denosumab-nxxp would require information from ongoing or planned clinical trials registered with regulatory authorities or published in medical literature.
For patients and clinicians interested in the potential expanded applications of denosumab-nxxp, monitoring clinical trial registries and forthcoming research publications would be advisable to stay informed about any developments in this area.
Incidence and Prevalence
Global Prevalence of Osteoporosis: Latest Estimates
Osteoporosis is increasingly becoming a global epidemic with an aging population and longer life span. Currently, it has been estimated that more than 200 million people are suffering from osteoporosis worldwide.
According to a 2022 systematic review and meta-analysis, the global prevalence of osteoporosis was 19.7% (95%CI, 18.0%-21.4%) and osteopenia was 40.4% (95%CI, 36.9%-43.8%). This prevalence varies significantly by geography, with rates ranging from 4.1% in Netherlands to 52.0% in Turkey. Continental variations show prevalence from 8.0% in Oceania to 26.9% in Africa. Notably, the prevalence was higher in developing countries (22.1%, 95%CI, 20.1%-24.1%) than in developed countries (14.5%, 95%CI, 11.5%-17.7%).
The International Osteoporosis Foundation reports that worldwide, 1 in 3 women over the age of 50 years and 1 in 5 men will experience osteoporotic fractures in their lifetime. The chief debilitating consequence, fracture, will affect about half the women and a third of the men in their lifetime.
Regional data shows significant variations:
In mainland China, a 2020 study found the standardized prevalence ranged from 5.04% to 7.46% in males aged ≥50 years and from 26.28% to 39.19% in females aged ≥50 years from 1990 to 2050. A 2023 study in Jiangsu, China found prevalence of 5.52% in urban and 10.33% in rural populations, with rates of 2.68% in males and 13.82% in females.
In Jordan, a 2024 study found the overall prevalence among postmenopausal women was 37.5% for osteoporosis and 44.6% for osteopenia.
A 2024 systematic review on osteosarcopenia (concurrent osteopenia/osteoporosis and sarcopenia) found a pooled prevalence of 18.5% (95% CI: 16.7-20.3), with regional variations: 22.9% in Oceania, 21.6% in Asia, 20.8% in South America, 15.7% in North America and 10.9% in Europe.
In the United States, osteoporosis is present in 24 million people (mostly women) and contributes to more than 1.3 million fractures/year.
Studies in Hispanic populations found the prevalence of osteopenia was 42% for the lumbar spine and 56% for the femoral neck, with osteoporosis at 12% for the lumbar spine and 8.7% for the femoral neck.
Risk factors include age, female gender, low BMI, physical inactivity, family history, inadequate sun exposure, high caffeine intake, low calcium intake, and delayed menarche. A 2025 study found that female participants had significantly higher odds of bone disorder, while obese and overweight individuals had lower odds compared to those of normal weight.
Osteoporosis results in decreased quality of life, increased disability-adjusted life span, and significant financial burden to health systems. With early diagnosis through bone mineral density assessment and timely treatment, osteoporosis can be prevented, highlighting the importance of awareness among healthcare providers and the general population.