{"id":10286,"date":"2025-08-13T17:16:57","date_gmt":"2025-08-13T17:16:57","guid":{"rendered":"https:\/\/organonpro.com\/en-us\/product\/bildyos-3\/why-bildyos\/"},"modified":"2025-10-29T14:30:38","modified_gmt":"2025-10-29T14:30:38","slug":"why-bildyos","status":"publish","type":"product","link":"https:\/\/organonpro.com\/en-us\/product\/bildyos\/why-bildyos\/","title":{"rendered":"Why BILDYOS"},"content":{"rendered":"\n<h1 class=\"wp-block-heading has-text-color has-link-color wp-elements-25bb1cf8dd7af4166edc37da94449ea6\" style=\"color:#037795\">What BILDYOS offers<\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">Potential cost savings<\/h2>\n\n\n\n<p>Current biologic osteoporosis treatments may be expensive, and PROLIA (denosumab) is one of the more expensive medications covered by Medicare.<sup>13,14 <\/sup><strong>As of 2025, BILDYOS is<strong> ~55%<\/strong> less expensive than PROLIA.*<\/strong> Referenced prices are derived from published price lists and do not necessarily reflect actual prices paid by consumers or dispensers. Lower acquisition costs alone do not necessarily reflect a cost advantage in the outcome of the condition treated because there are other variables that affect relative costs.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><br><sup>*<\/sup>Based on comparison of wholesale acquisition cost (WAC) per injection. WAC prices: BILDYOS $844.00 per injection; PROLIA $1,875.43 per injection (Source: Medi-Span<sup>\u00ae<\/sup> Price Rx<sup>\u00ae <\/sup>as of Sept 2025).<\/p>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">BILDYOS is as safe and effective as the reference product, PROLIA<sup>1<\/sup><\/h2>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button internal-scroll-btn-new\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/organonpro.com\/en-us\/product\/bildyos\/why-bildyos\/#biosimilar\" style=\"background-color:#d53179\">See a clinical overview<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/09\/CampaignImage.png\" alt=\"\"\/><\/figure><\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-1154fdc78514e67c24f324d83ca5a994\"><br><br>Choose BILDYOS, a biosimilar to PROLIA (denosumab) with no clinically meaningful differences in safety, purity, and potency<sup>1<\/sup><\/h2>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h1 class=\"wp-block-heading has-text-color has-link-color wp-elements-58b83b25dab7f49e6f1ad617fa4d478b\" id=\"biosimilar\" style=\"color:#037795\">BILDYOS is an approved biosimilar to PROLIA<\/h1>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/09\/ComparisonChart_a6c196.png\" alt=\"\"\/><\/figure><\/div>\n\n\n<p class=\"has-text-align-left has-small-font-size\">  PD, pharmacodynamic; PK, pharmacokinetic.<\/p>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Pharmacokinetic similarity study<sup>16<\/sup>:<\/h2>\n\n\n\n<p>A 2-part pharmacokinetic similarity study of BILDYOS (HLX14) and reference denosumab demonstrated biosimilarity in PK, PD, safety, and immunogenicity endpoints.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons internal-scroll-btn-new is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/organonpro.com\/en-us\/product\/bildyos\/why-bildyos\/#comparative-clinical-study\" style=\"background-color:#d53179\">See efficacy data<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">BILDYOS is FDA approved and has the same 5 indications as PROLIA, including for the treatment of postmenopausal women with osteoporosis at high risk for fracture<\/h2>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n    <section class=\"advance-accordion advance-accordion\" id=\"advance-accordion-block_a1e56aac6b4bd3c767550037e09b2de5\">\n        <div class=\"container\">\n                        <div class=\"row\">\n                <div class=\"col-xl-12 p-0\">\n                    <div class=\"accordion-org accordion-oc accordion-default\"\n                        id=\"advance-accordion-block_a1e56aac6b4bd3c767550037e09b2de5ac\">\n                                                            <div class=\"accordion-item\">\n                                        <h4 class=\"accordion-header\"\n                                            id=\"advance-accordion-block_a1e56aac6b4bd3c767550037e09b2de5heading1\">\n                                            <button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\"\n                                                data-bs-target=\"#advance-accordion-block_a1e56aac6b4bd3c767550037e09b2de5collapse1\"\n                                                aria-expanded=\"false\" aria-controls=\"collapseThree\">\n                                                BILDYOS is approved for the following indications                                                <ion-icon name=\"chevron-down-outline\"><\/ion-icon>\n                                            <\/button>\n                                        <\/h4>\n                                        <div id=\"advance-accordion-block_a1e56aac6b4bd3c767550037e09b2de5collapse1\"\n                                            class=\"accordion-collapse collapse\"\n                                            aria-labelledby=\"advance-accordion-block_a1e56aac6b4bd3c767550037e09b2de5heading1\"\n                                             data-bs-parent=\"#advance-accordion-block_a1e56aac6b4bd3c767550037e09b2de5ac\" >\n                                            <div class=\"accordion-body\">\n                                                <ul>\n<li>Treatment of postmenopausal women with osteoporosis at high risk for fracture<\/li>\n<li>Treatment to increase bone mass in men with osteoporosis at high risk for fracture<\/li>\n<li>Treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture<\/li>\n<li>Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer<\/li>\n<li>Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer<\/li>\n<\/ul>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                                                        <\/div>\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/section>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Support your patients through access<\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-buttons is-content-justification-left is-layout-flex wp-container-core-buttons-is-layout-fdcfc74e wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/organonpro.com\/en-us\/product\/bildyos\/savings-support\/\" style=\"background-color:#d53179\">Explore patient access<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-buttons is-content-justification-left is-layout-flex wp-container-core-buttons-is-layout-fdcfc74e wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--1\"><a class=\"wp-block-button__link has-white-background-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/organonpro.com\/en-us\/product\/bildyos\/about-organon\/#organon-powers\" style=\"border-radius:100px;color:#d53179\">See our experience<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h1 class=\"wp-block-heading has-text-color has-link-color wp-elements-67dffb85cd7bf837725313e5fd53f072\" id=\"comparative-clinical-study\" style=\"color:#026c88\">Comparative clinical study<\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">Randomized, double-blind, parallel-controlled, multicenter comparative clinical study in postmenopausal women with osteoporosis at high risk for fracture<sup>15<\/sup><\/h2>\n\n\n\n<p>Between June 17, 2022, and June 5, 2024, the study enrolled 514 postmenopausal women between the ages of 60 and 90 with osteoporosis at high risk for fracture. All had BMD T-scores between -2.5 and -4.0 at the lumbar spine or total hip. Eligible patients were randomized 1:1 to receive 60 mg BILDYOS (HLX14) or 60 mg EU-denosumab (PROLIA) every 6 months. At Week 52, prior to dose 3, the PROLIA group was re-randomized 1:1 to stay on their initial therapy or switch to BILDYOS, while 220 patients already on BILDYOS continued with a third dose of BILDYOS.<sup>15,\u2020<\/sup><\/p>\n\n\n\n<p><a href=\"https:\/\/organonpro.com\/en-us\/product\/bildyos\/why-bildyos\/\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/09\/ClinicalTrial_0e9bea.png\" alt=\"\"\/><\/figure><\/div>\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-align-left has-small-font-size\"><\/p>\n\n\n\n<p class=\"has-text-align-center has-small-font-size\"><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:4%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:95%\">\n<p class=\"has-small-font-size\"><sup>\u2020<\/sup>Participants were required to take at least 1,000 mg of calcium and at least 400 IU of vitamin D daily.<sup>15<\/sup><br><sup>\u2021<\/sup>74 participants from treatment period 1 did not continue to receive treatment in treatment period 2.<sup>15<\/sup><\/p>\n\n\n\n<p class=\"has-small-font-size\">BMD, bone mineral density; EU, European Union; IU, international unit; SC, subcutaneous.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\">Primary efficacy endpoint<sup>15<\/sup>:<\/h3>\n\n\n\n<p>Percent change in BMD at the lumbar spine from baseline to Week 52 (Day 365) as assessed by central imaging.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:10%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\">Primary PD endpoint<sup>15<\/sup>:<\/h3>\n\n\n\n<p>Area under the effect-time curve for percent change of s-CTX from baseline to Week 26 (AUEC<sub>0\u201326W<\/sub>) (Day 183).<\/p>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Secondary endpoints<sup>15<\/sup>:<\/h3>\n\n\n\n<p>Percent changes in BMD at the lumbar spine from baseline to Weeks 26, 52, and 78 (assessed by Investigator); fracture rate from baseline to Weeks 52 and 78; percent changes in BMD at the lumbar spine from baseline to Weeks 26 and 78 (assessed by the central imaging); percent changes in BMD at total hip from baseline to Weeks 26, 52, and 78 (assessed by the central imaging and Investigator); percent changes in BMD at the femoral neck from baseline to Weeks 26, 52, and 78 (assessed by the central imaging and Investigator); relative percent changes in s-CTX from baseline to D15, D29, D57, D92, D106, D134, D162, D183 (within 7 days prior to the second dose), D274, D365 (within 7 days prior to the third dose), and D547 (at the end-of-study visit); relative percent changes in serum procollagen type 1 N propeptide (s-P1NP) from baseline to D15, D29, D57, D92, D106, D134, D162, D183 (within 7 days prior to the second dose), D274, D365 (within 7 days prior to the third dose), and D547 (at the end-of-study visit).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Eligible participants<sup>15<\/sup><\/h3>\n\n\n\n<p>Postmenopausal women with osteoporosis aged 60\u201390 years with BMD T-scores between -2.5 and -4.0 at the lumbar spine or total hip as assessed by central imaging at the time of screening, at least 2 vertebrae in the L1\u2013L4 region of lumbar spine, and at least 1 hip evaluable by DXA.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><br>D, day; DXA, dual-energy X-ray absorptiometry; s-CTX, serum C-terminal telopeptide of type 1 collagen.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Exclusion criteria included<sup>15<\/sup>:<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Diseases that may affect bone metabolism\u2028<\/li>\n\n\n\n<li>Thyroid disorders\u2028<\/li>\n\n\n\n<li>Rheumatoid arthritis and ankylosing spondylitis\u2028<\/li>\n\n\n\n<li>Active malignancies\u2028<\/li>\n\n\n\n<li>Malabsorption syndrome or various gastrointestinal disorders associated with malabsorption<\/li>\n<\/ol>\n\n\n\n<p>This is not the full list of exclusion criteria.<\/p>\n\n\n    <section class=\"advance-accordion advance-accordion accordion-with-ol-start-6\" id=\"advance-accordion-block_649d93f974ebd0ac90dd3b9a1e4fd32c\">\n        <div class=\"container\">\n                        <div class=\"row\">\n                <div class=\"col-xl-12 p-0\">\n                    <div class=\"accordion-org accordion-oc accordion-default\"\n                        id=\"advance-accordion-block_649d93f974ebd0ac90dd3b9a1e4fd32cac\">\n                                                            <div class=\"accordion-item\">\n                                        <h4 class=\"accordion-header\"\n                                            id=\"advance-accordion-block_649d93f974ebd0ac90dd3b9a1e4fd32cheading1\">\n                                            <button class=\"accordion-button collapsed\" type=\"button\" data-bs-toggle=\"collapse\"\n                                                data-bs-target=\"#advance-accordion-block_649d93f974ebd0ac90dd3b9a1e4fd32ccollapse1\"\n                                                aria-expanded=\"false\" aria-controls=\"collapseThree\">\n                                                See the continued list of exclusion criteria<sup>15<\/sup>                                                <ion-icon name=\"chevron-down-outline\"><\/ion-icon>\n                                            <\/button>\n                                        <\/h4>\n                                        <div id=\"advance-accordion-block_649d93f974ebd0ac90dd3b9a1e4fd32ccollapse1\"\n                                            class=\"accordion-collapse collapse\"\n                                            aria-labelledby=\"advance-accordion-block_649d93f974ebd0ac90dd3b9a1e4fd32cheading1\"\n                                             data-bs-parent=\"#advance-accordion-block_649d93f974ebd0ac90dd3b9a1e4fd32cac\" >\n                                            <div class=\"accordion-body\">\n                                                <ol>\n<li>Severe renal impairment due to renal disease with a glomerular filtration rate &lt;30 mL\/min<\/li>\n<li>Hepatic diseases<\/li>\n<li>Serious primary diseases in the cardiovascular, cerebrovascular, or hematopoietic system judged by Investigator<\/li>\n<li>Positive for human immunodeficiency virus (HIV) antibody<\/li>\n<li>Vitamin D deficiency<\/li>\n<li>Abnormal serum calcium<\/li>\n<li>Oral and dental diseases<\/li>\n<li>Active or uncontrolled infection requiring systemic therapy within 2 weeks prior to first dose<\/li>\n<li>Type 1 diabetic patients, or type 2 diabetic patients who had poor blood glucose control or were treated with insulin, glucagon-like peptide 1 (GLP-1), thiazolidinediones, sodium-glucose cotransporter 2 (SGLT2) inhibitors, etc<\/li>\n<li>Participating in clinical trials of other medical devices or drugs or within 30 days or 5 half-lives after the last visit in the clinical trials of other medical devices or drugs (non-bone metabolism related drugs) (whichever was longer, started from the date of informed consent form [ICF] signing). Bone metabolism related drugs should comply with the corresponding prohibition time limit, and anti-osteoporosis drugs should be excluded. Those who had failed in the screening period of other clinical trials but had not yet been treated with other drugs\/clinical devices could be included in this study<\/li>\n<li>Had received denosumab and its biosimilars, or romosozumab and its biosimilars, or cathepsin K inhibitor therapy prior to randomization<\/li>\n<li>Had received the following osteoporosis treatments, or medications that affected bone metabolism or any herbal medications:<br \/>\n\u2022 Use of bisphosphonates (oral or intravenous), fluoride and strontium prior to randomization<br \/>\n\u2022 Use of parathyroid hormone (PTH) or PTH analogues, such as teriparatide, within 12 months prior to randomization<br \/>\n\u2022 Use of systemic hormone replacement therapy (HRT), selective estrogen receptor modulators, tibolone, anabolic hormones, testosterone, androgens, gonadotropin-releasing hormone agonists, or adrenocorticotropic hormone, within 12 months prior to randomization<br \/>\n\u2022 Use of calcitonin, calcitriol, alfacalcidol or vitamin D analogues within 12 months prior to randomization<br \/>\n\u2022 Use of any of the following within 3 months prior to randomization: heparin, warfarin, anticonvulsants (except benzodiazepines), systemic use of ketoconazole, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and oral or parenteral glucocorticoids (\u22655 mg\/day prednisone daily or equivalent for &gt;10 days)<br \/>\n\u2022 Use of any herbal medications within 2 weeks (if the herbal medications contained the above components that affected bone metabolism, the corresponding elution process of bone metabolism components should be followed)<\/li>\n<li>Subjects with a history or presence of hip fracture or prevalent vertebral fracture (any severe or more than 2 moderate prevalent vertebral fractures)<\/li>\n<li>Presence of active healing fracture in the opinion of the Investigator<\/li>\n<li>Subjects at very high risk of fracture who must be treated immediately with an active drug in the opinion of the Investigator<\/li>\n<li>Known allergy to the drugs listed in the study protocol, including a history of allergy to denosumab, any recombinant protein drugs, or any ingredients used in HLX14 or PROLIA<\/li>\n<li>With a history and presence of smoking, except for the following situation:<br \/>\n\u2022 Nonsmokers (a history of never smoking &gt;5 cigarettes\/day and not smoking at all for at least the last 2 years prior to screening process)<br \/>\n\u2022 Light smokers (with smoking habit &lt;5 cigarettes\/day, smoking period &lt;10 years. Light smokers should have not smoked more than 1 cigarette in the week before starting the medical screening process)<\/li>\n<li>With a history of drug or alcohol abuse, and with evidence of alcohol or drug abuse within 12 months<\/li>\n<li>Various physical or psychiatric disorders or laboratory abnormalities which, in the opinion of the Investigator, would prevent the subject from following the study procedures and completing the study, or interfere with the interpretation of study results. Or subjects who had other conditions rendering them unsuitable for inclusion as judged by the Investigator<\/li>\n<\/ol>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                                                        <\/div>\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/section>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h1 class=\"wp-block-heading has-text-color has-link-color wp-elements-03ad976fd04017a9827161c183146df8\" style=\"color:#026c88\">In postmenopausal women with osteoporosis, efficacy results of BILDYOS were similar to PROLIA<\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">BILDYOS (HLX14) and PROLIA increased BMD at the lumbar spine at Week 52<sup>15<\/sup><\/h2>\n\n\n\n<p>From baseline to Week 52, both the BILDYOS and the PROLIA groups increased lumbar spine BMD. The adjusted mean difference between the 2 groups was 0.23% (<em>P<\/em>=0.518).<sup>15<\/sup><\/p>\n\n\n\n<p>The 90% CI and 95% CI for the difference both fell within the prespecified equivalence margins of \u22121.45% to 1.45%.<sup>15<\/sup><\/p>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/10\/ComparableEfficacy.svg\" alt=\"\"\/><\/figure><\/div>\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p class=\"has-small-font-size\"><sup>\u00a7<\/sup>Based on the ITT set, with the application of hypothesis strategy for handling intercurrent events, the mean (SD) percent changes from baseline to Week 52 in BMD at the lumbar spine assessed by the central imaging for subjects in the HLX14 and PROLIA groups were 6.10% (3.951%) and 5.90% (3.834%), respectively.<br><sup>||<\/sup>Adjusted for baseline BMD values and BMI stratification factor (&lt;25, 25-30, &gt;30) using the ANCOVA model.<sup>15<\/sup><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p class=\"has-small-font-size\">ANCOVA, analysis of covariance; BMI, body mass index; CI, confidence interval; ITT, intention-to-treat; SD, standard deviation.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h1 class=\"wp-block-heading has-text-color has-link-color wp-elements-23544affb23ac0d06a4d94b37ae3e72b\" style=\"color:#026c88\">BILDYOS has similar PD and PK to PROLIA<sup>15<\/sup><\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">In the pharmacodynamic set (PDS)<sup>15<\/sup>:<\/h2>\n\n\n\n<p>The primary PD endpoint analysis results of AUEC<sub>0-26W<\/sub> for percent change from baseline of s-CTX of BILDYOS (HLX14) and PROLIA were equivalent between BILDYOS and PROLIA.<sup>15<\/sup><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Statistical analysis:<\/h3>\n\n\n\n<p>The geometric LS mean ratio of AUEC<sub>0-26W<\/sub> (primary PD endpoint) for participants in the BILDYOS group vs PROLIA group was 1.01 (90% CI: 0.99, 1.04; 95% CI: 0.98, 1.05), and the 90% CI and 95% CI for the geometric LS mean ratio of AUEC<sub>0-26W<\/sub> both fell within the prespecified equivalence margins (0.8, 1.25), demonstrating the PD equivalence between BILDYOS and PROLIA. The supplementary analysis results were consistent with the primary PD results, further supporting the PD equivalence between BILDYOS and PROLIA.<sup>15<\/sup><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">In the pharmacokinetic set (PKS)<sup>15<\/sup>:<\/h2>\n\n\n\n<p>After administration of BILDYOS and PROLIA, the serum denosumab concentration profiles were broadly superimposable.<\/p>\n\n\n\n<p>Serum denosumab concentrations at each timepoint were similar between groups across the different treatment periods (BILDYOS and PROLIA groups in treatment period 1 [from baseline to Week 52]; BILDYOS\/BILDYOS, PROLIA\/BILDYOS, and PROLIA\/PROLIA groups in treatment period 2 [from Week 52 to Week 78]). A single transition treatment from PROLIA to BILDYOS did not impact the PK evaluation results.<sup>15<\/sup><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Statistical analysis:<\/h3>\n\n\n\n<p>For treatment period 1 and treatment period 2, serum concentrations of BILDYOS and PROLIA were summarized at nominal sample time according to treatment group by the number of below the limit of quantification (BLQ); number of observations; maximum, median, minimum, and standard deviation; arithmetic mean; geometric mean (geomean); CV; and geometric CV (CVb%).<sup>15<\/sup><\/p>\n\n\n\n<p class=\"has-small-font-size\">CV, coefficient of variation; CVb, coefficient of variation between batches; LS, least squares.<\/p>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/09\/MeanChart_906d2e.png\" alt=\"\"\/><\/figure><\/div>\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:8%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:91%\">\n<p class=\"has-small-font-size\">\u2191: Receiving the study treatment.<br>n for D0\u2013365: Number of subjects in the pharmacokinetic set.<br>n for D365\u2013547: Number of subjects in the pharmacokinetic set and receiving the third dose.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h1 class=\"wp-block-heading has-text-color has-link-color wp-elements-84089ef5f795417f699a947e04991e9b\" style=\"color:#026c88\">BILDYOS and PROLIA have similar safety profiles<\/h1>\n\n\n\n<p>Based on the safety set, 452 (87.9%) participants experienced treatment emergent adverse events (TEAEs), including 222 (86.7%) participants in the HLX14 group and 230 (89.1%) in the PROLIA group.<sup>15<\/sup>\u2028<\/p>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/09\/SummaryChart_fd5b27.png\" alt=\"\"\/><\/figure><\/div>\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:7%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p class=\"has-small-font-size\">N: The number of subjects in the analysis set.<br>n: The number of subjects in specific category; %: (n\/N*100).<\/p>\n\n\n\n<p class=\"has-small-font-size\">TEAE (Week 0 to Week 52) was defined as an AE that first occurred or worsened in severity between the first dose administration and the third dose administration (exclusive) for subjects who entered treatment period 2, or to the end for those who did not enter treatment period 2.<sup>15<\/sup><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:7%\"><\/div>\n<\/div>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Extension safety set<\/h2>\n\n\n\n<p>Based on the extension safety set, 316 (71.8%) subjects experienced TEAEs, including 153 (69.5%) subjects in the HLX14\/HLX14 group, 84 (76.4%) subjects in the PROLIA\/HLX14 group and 79 (71.8%) subjects in the PROLIA\/PROLIA group.<sup>15<\/sup><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/09\/SummaryExtChart_e0099b.png\" alt=\"\"\/><\/figure><\/div>\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p class=\"has-small-font-size\">N: The number of subjects in the analysis set.<br>n: The number of subjects in specific category; %: (n\/N*100).<\/p>\n\n\n\n<p class=\"has-small-font-size\">TEAE for treatment period 2 (\u201cfrom Week 52 to Week 78\u201d) was defined as an AE that first occurred or worsened in severity in the period from the third dose administrated date to the end for the subjects who entered the treatment period 2.<sup>15<\/sup><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:7%\"><\/div>\n<\/div>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h1 class=\"wp-block-heading has-text-color has-link-color wp-elements-196f5f9731286683a700c7b41280f268\" style=\"color:#026c88\">Similar immunogenicity to PROLIA<\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">Antidrug antibodies (ADAs) and neutralizing antibodies (NAbs) were similar between BILDYOS (HLX14) and PROLIA<sup>15<\/sup><\/h2>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/09\/ImmunoChart_49f0ab.png\" alt=\"\" style=\"width:678px\"\/><\/figure><\/div>\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:7%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p class=\"has-small-font-size\"><sup>\u00b6<\/sup>Treatment periods 1 and 2 are combined from baseline to Week 78.<\/p>\n\n\n\n<p class=\"has-small-font-size\">HLX14 use only means subject used HLX14 in treatment period 1 and discontinued or continued to use HLX14 in treatment period 2.<sup>15<\/sup><\/p>\n\n\n\n<p class=\"has-small-font-size\">PROLIA use only means subject who used PROLIA in treatment period 1 and discontinued or continued to use PROLIA in treatment period 2.<sup>15<\/sup><\/p>\n\n\n\n<p class=\"has-small-font-size\">Overall positive rate for ADA\/NAb was calculated as the number of subjects who have received at least 1 dose of the study drug with positive results\/the total number of subjects with at least 1 ADA testing result post-dose administration.<sup>15<\/sup><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:7%\"><\/div>\n<\/div>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/08\/thumbnail.png\" alt=\"\"\/><\/figure><\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h2 class=\"wp-block-heading\">Learn how BILDYOS is administered<\/h2>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/organonpro.com\/en-us\/product\/bildyos\/dosing-administration\/\" style=\"background-color:#d53179\">Dosing &amp; administration<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<script>\ndocument.querySelectorAll('.accordion-with-ol-start-6').forEach(function(container) {\n  const firstOl = container.querySelector('ol');\n  if (firstOl) {\n    firstOl.setAttribute('start', '6');\n  }\n});\n<\/script>\n","protected":false},"author":65,"featured_media":0,"parent":10280,"menu_order":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"product_categories":[],"product_specialization":[],"customer_type":[],"class_list":["post-10286","product","type-product","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.11 (Yoast SEO v26.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BILDYOS\u00ae (denosumab-nxxp) | Why BILDYOS<\/title>\n<meta name=\"description\" content=\"Learn more about BILDYOS\u00ae (denosumab-nxxp), including the studies thatsupported its approval, and potential cost savings.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/organonpro.com\/en-us\/product\/bildyos\/why-bildyos\/\" \/>\n<meta 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