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FDA Approves Bildyos

FDA Approves Bildyos (denosumab-nxxp), a Biosimilar to Prolia

September 2025

SHANGHAI, China & JERSEY CITY, NJ – September 2, 2025 – 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, a biosimilar to Prolia (denosumab), for all indications of the reference product.1,2

The FDA also approved Bilprevda (denosumab-nxxp) injection 120 mg/1.7 mL, a biosimilar to Xgeva (denosumab), for all indications of the reference product.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.

“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

References

1. Prolia. Prescribing Information. Amgen Inc.; 2025.

2. Xgeva. Prescribing Information. Amgen Inc.; 2025.

3. Office of Women’s Health. Osteoporosis. US Food and Drug Administration. May 13, 2024. Accessed December 4, 2024. https://www.fda.gov/consumers/womens-health-topics/osteoporosis

4. Biosimilars in the United States: providing more patients greater access to lifesaving medicines. Biosimilars Council. 2017. Accessed July 25, 2025. https://biosimilarscouncil.org/wp-content/uploads/2019/03/Biosimilars-Council-Patient-Access-Study.pdf

5. Overview for health care professionals. US Food and Drug Administration. Updated August 1, 2024. Accessed March 13, 2025. https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals

6. Aitken M, Kleinrock M, Pritchett J. Biosimilars in the United States 2023-2027: competition, savings, and sustainability. IQVIA Institute for Human Data Science. January 31, 2023. Accessed January 7, 2025.

7. Biosimilars basics for patients. US Food and Drug Administration. May 7, 2024. Accessed September 1, 2024. https://www.fda.gov/drugs/biosimilars/biosimilars-basics-patients

8. Review and approval. US Food and Drug Administration. December 13, 2022. Accessed July 28, 2025. https://www.fda.gov/drugs/biosimilars/review-and-approval

9. Biosimilar product regulatory review and approval. US Food and Drug Administration. Accessed May 1, 2025. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf

10. Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed July 28, 2025. https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-Prolia-Xgeva-denosumab-biosimilar-candidates/

11. HADLIMA. Prescribing Information. Organon; 2024.

12. ONTRUZANT. Prescribing Information. Organon; 2025.

13. RENFLEXIS. Prescribing Information. Organon; 2023.

14. TOFIDENCE. Prescribing Information. Organon; 2025.

About Bildyos (denosumab-nxxp)

Bildyos is a RANK ligand (RANKL) inhibitor indicated for/to:

SELECTED SAFETY INFORMATION

SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
Patients with advanced chronic kidney disease (eGFR <30mL/min/1.73m2), including dialysis dependent patients, are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events, and fatal cases have been reported.

The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients.

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 health care provider with expertise in the diagnosis and management of CKD-MBD.

CONTRAINDICATIONS

Bildyos is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Bildyos. Bildyos is contraindicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Bildyos. Bildyos is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling, and urticaria.

WARNINGS AND PRECAUTIONS

Severe Hypocalcemia and Mineral Metabolism Changes
Denosumab products can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Bildyos. Adequately supplement all patients with calcium and vitamin D.

In patients without advanced chronic kidney disease who are predisposed to hypocalcemia and disturbances of mineral metabolism (eg, treatment with other calcium lowering drugs), assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after BILYDOS injection.

Drug Products with Same Active Ingredient
The active ingredient in Bildyos is denosumab. Patients receiving Bildyos should not receive other denosumab products concomitantly.

Hypersensitivity
Clinically significant hypersensitivity, including anaphylaxis, has been reported with denosumab products. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Bildyos.

Osteonecrosis of the Jaw (ONJ)
ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing. ONJ has been reported in patients receiving denosumab products. A routine oral exam should be performed by the prescriber prior to initiation of Bildyos. A dental examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery), diagnosis of cancer, concomitant therapies (eg, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (eg, periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). Good oral hygiene practices should be maintained during treatment with Bildyos. Concomitant administration of drugs associated with ONJ may increase the risk of developing ONJ. The risk of ONJ may increase with duration of exposure to denosumab products.

For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit-risk assessment.

Patients who are suspected of having or who develop ONJ while on Bildyos should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of Bildyos should be considered based on individual benefit-risk assessment.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures
Atypical low-energy, or low trauma fractures of the shaft have been reported in patients receiving denosumab products. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents.

During Bildyos treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Interruption of Bildyos therapy should be considered, pending a benefit-risk assessment, on an individual basis.

Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment
Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of denosumab. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab product discontinuation. Evaluate an individual’s benefit-risk before initiating treatment. If Bildyos treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy.

Serious Infections
In a clinical trial of over 7800 women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the denosumab group than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with denosumab products. Endocarditis was also reported more frequently in denosumab-treated patients. The incidence of opportunistic infections and the overall incidence of infections were similar between the treatment groups. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis.

Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. Consider the benefit-risk profile in such patients before treating with Bildyos. In patients who develop serious infections while on Bildyos, prescribers should assess the need for continued Bildyos therapy.

Dermatologic Adverse Reactions
In a clinical trial of over 7800 women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate with denosumab treatment compared to placebo. Most of these events were not specific to the injection site. Consider discontinuing Bildyos if severe symptoms develop.

Musculoskeletal Pain
In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients during denosumab treatment. Onset of symptoms varied from one day to several months after starting denosumab products. Consider discontinuing use if severe symptoms develop.

Suppression of Bone Turnover
In clinical trials in women with postmenopausal osteoporosis, treatment with denosumab resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance of these findings and the effect of long-term treatment with denosumab products are unknown. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing.

Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta
Bildyos is not approved for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products.

ADVERSE REACTIONS

The most common adverse reactions (>5% and more common than placebo) reported with denosumab products in women with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.

The most common adverse reactions (>5% and more common than placebo) reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. Pancreatitis has been reported with denosumab products.

The most common adverse reactions (>3% and more common than active-control group) reported with denosumab products in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache.

The most common (per patient incidence ≥10%) adverse reactions reported with denosumab products in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.

The most common adverse reactions leading to discontinuation of denosumab products in patients with postmenopausal osteoporosis are back pain and constipation.

Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Before prescribing Bildyos, please read the Prescribing Information (https://www.organon.com/product/usa/pi_circulars/b/Bildyos/Bildyos_pi.pdf), including the Boxed Warning about severe hypocalcemia. The Medication Guide (https://www.organon.com/product/usa/pi_circulars/b/Bildyos/Bildyos_mg.pdf) also is available.

Please note, Bildyos is part of the Risk Evaluation and Mitigation Strategy (REMS) program.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn (https://www.linkedin.com/company/organon/), Instagram (https://www.instagram.com/organonllc/), X (https://x.com/OrganonLLC), YouTube (https://www.youtube.com/channel/UCFXZcWljXuEhDkMCmZZ4Yzw), TikTok (https://www.tiktok.com/@organon_llc) and Facebook .

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about expectations regarding the business opportunities and prospects for Bildyos and Bilprevda. Forward-looking statements may be identified by words such as “will,” “potential,” “aim,” “explore,” “opportunity,” “expect,” “future,” “working to,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to market Bildyos and Bilprevda; factors that could adversely affect the level of demand for Bildyos and Bilprevda (including trade protection measures and import or export licensing requirements; changes in US and foreign federal, state, and local governmental funding allocations, including the timing and amounts allocated to Organon’s customers and business partners; and economic factors); the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid, and health care reform, pharmaceutical reimbursement, and pricing in general; manufacturing difficulties or delays; restructurings or other disruptions at the FDA and other government agencies; efficacy, safety, or other quality concerns; and future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits, and forgoing health care insurance coverage. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings (including Organon’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025), available at the SEC’s Internet site (www.sec.gov). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.

Prolia and Xgeva are trademarks registered in the US by Amgen, Inc.; Organon is not associated with this trademark owner.

Source: Shanghai Henlius Biotech, Inc. and Organon

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Bildyos (denosumab-nxxp) FDA Approval History

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