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FDA Approves Bilprevda

FDA Approves Bilprevda (denosumab-nxxp), a Biosimilar to Xgeva

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 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 also approved Bildyos (denosumab-nxxp) injection 60 mg/mL, a biosimilar to Prolia (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

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

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 Bilprevda (denosumab-nxxp)

Bilprevda is a RANK ligand (RANKL) inhibitor indicated for:

SELECTED SAFETY INFORMATION

CONTRAINDICATIONS

Pre-existing hypocalcemia must be corrected prior to initiating therapy with Bilprevda. Bilprevda is contraindicated in patients with known clinically significant hypersensitivity to denosumab products.

WARNINGS AND PRECAUTIONS

Drug Products with Same Active Ingredient
Patients receiving Bilprevda should not receive other denosumab products concomitantly.

Hypocalcemia
Denosumab products can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating Bilprevda. Monitor calcium levels throughout therapy, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk, and serum calcium should be closely monitored. Advise patients to contact a health care provider for symptoms of hypocalcemia.

An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.

Hypersensitivity
Bilprevda is contraindicated in patients with known clinically significant hypersensitivity to denosumab products, including anaphylaxis. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue Bilprevda therapy permanently.

Osteonecrosis of the Jaw (ONJ)
ONJ has been reported in patients receiving denosumab products, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure.

A history of tooth extraction, poor oral hygiene, or use of a dental appliance may be predisposing factors to developing ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.

Perform an oral examination and appropriate preventive dentistry prior to the initiation of Bilprevda and periodically during therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with Bilprevda. Consider temporarily interrupting therapy if an invasive dental procedure must be performed.

Patients who are suspected of having or who develop ONJ while on Bilprevda should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

Atypical Subtrochanteric and Diaphyseal Femoral Fracture
Atypical femoral fracture has been reported with denosumab products. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (eg, prednisone) at the time of fracture. During Bilprevda 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. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of Bilprevda therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with Growing Skeletons

Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in denosumab-treated patients with GCTB and in patients with growing skeletons. Hypercalcemia has been reported within the first year after treatment discontinuation. After treatment is discontinued, monitor patients for signs and symptoms of hypercalcemia, assess serum calcium periodically, reevaluate the patients’ calcium and vitamin D supplementation, and treat appropriately.

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation
MVF have been reported following discontinuation of treatment with denosumab products. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When Bilprevda treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.

Embryo-Fetal Toxicity
Based on data from animal studies and its mechanism of actions, denosumab products can cause fetal harm when administered to a pregnant woman.

Verify the pregnancy status of females of reproductive potential prior to the initiation of Bilprevda. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of Bilprevda. Advise pregnant women and females of reproductive potential that exposure to Bilprevda during pregnancy or within 5 months prior to conception can result in fetal harm.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥25%) in patients with bone metastasis from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction was dyspnea. The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia.

The most common adverse reactions (incidence ≥10%) in patients with multiple myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction was pneumonia. The most common adverse reaction resulting in discontinuation was osteonecrosis of the jaw.

The most common adverse reactions (incidence ≥10%) in patients with GCTB were arthralgia, back pain, pain in extremity, fatigue, headache, nausea, nasopharyngitis, musculoskeletal pain, toothache, vomiting, hypophosphatemia, constipation, diarrhea, and cough. The most frequent serious adverse reactions were osteonecrosis of the jaw, bone giant cell tumor, anemia, pneumonia, and back pain. The most common adverse reaction resulting in discontinuation was osteonecrosis of the jaw.

The most common adverse reactions (incidence >20%) in patients with hypercalcemia of malignancy were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.

Before prescribing Bilprevda, please read the Prescribing Information (https://www.organon.com/product/usa/pi_circulars/b/Bilprevda/Bilprevda_pi.pdf).

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. (2696.HK), and Organon

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Bilprevda (denosumab-nxxp) FDA Approval History

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