RALEIGH, N.C., Nov. 20, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) approval of Jubereq (denosumab-desu), a biosimilar to Xgeva (denosumab). The FDA also approved Osvyrti (denosumab-desu), a biosimilar to Prolia (denosumab).1-2 The dual approvals mark Accord BioPharma's fourth and fifth biosimilars, demonstrating the company's continued growth in the U.S. market.

Jubereq was also approved for all indications of its reference product (Xgeva, developed by Amgen). Jubereq is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with 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 is likely to result in severe morbidity, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.2

"Both Osvyrti and Jubereq have been approved for a wide variety of bone-related indications, including osteoporosis and bone loss from the treatment of certain kinds of cancer," said Chrys Kokino, President, Accord North America. "These biosimilars have the potential to provide a large number of patients with treatment alternatives that lessen cost as a barrier to accessing proven therapies. At Accord, we are passionate about leading biosimilar adoption, and Osvyrti and Jubereq represent significant steps in our mission to make biosimilars more accessible."

In 2024, global Prolia sales increased 8% year over year to more than $4.374 billion, while Xgeva revenues climbed 5% to $2.225 billion, putting both products among Amgen's top five highest-selling drugs.3

The approval of Osvyrti and Jubereq is based on results from two trials: a Phase I trial and a Phase III trial that met their primary endpoints. The Phase I trial was a randomized, double-blind, three-arm pharmacokinetic (PK) study comparing Jubereq to Xgeva in healthy adult males. The study demonstrated that PK parameters were found to be comparable between the two products.4 The Phase III study was a randomized, double-blind, active-controlled, parallel arm, multicenter study comparing PK/PD, efficacy and safety of Osvyrti to Prolia in postmenopausal women with osteoporosis. The clinical study results demonstrated that Osvyrti and its reference product, Prolia, are highly similar, and have no clinically meaningful differences in terms of PK, PD, safety and efficacy.2,4

Accord is currently working to commercialize Osvyrti and Jubereq and bring these brands to the marketplace in 2026. More details will be provided closer to availability.

"Osvyrti and Jubereq are the first biosimilars Accord has developed completely on its own, and we will manufacture these products internally without a third-party partnership," said Mr. Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "We believe biosimilars are here to stay, and we are investing in their promise of cost savings for patients and the entire U.S. healthcare system."

Accord BioPharma's portfolio has experienced sizable growth within the past year. The company assumed U.S. operations earlier this year for the full UDENYCA® (pegfilgrastim-cbqv) franchise, including the UDENYCA pre-filled syringe, the UDENYCA autoinjector, and UDENYCA ONBODY®. Accord BioPharma is also marketing IMULDOSA® (ustekinumab-srlf), a biosimilar to Stelara® (ustekinumab), HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), and CAMCEVI® (leuprolide) 42 mg injectable emulsion. Please refer to the Important Safety Information and full Prescribing Information for all products, and to the Boxed Warning for HERCESSI.

Intas Pharmaceuticals, Ltd. has an exclusive agreement with Bio-Thera Solutions to enable Accord BioPharma to bring Bio-Thera's golimumab candidate BAT2506 – a biosimilar to Simponi® (golimumab) – to the U.S. market.

IMPORTANT SAFETY INFORMATION FOR Jubereq® (denosumab-desu) injection, for subcutaneous use

Jubereq® (denosumab-desu) is biosimilar to Xgeva® (denosumab)]

IMPORTANT SAFETY INFORMATION

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

Same Active Ingredient: Patients receiving Jubereq should not receive other denosumab products concomitantly.

Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis has been reported with denosumab products. 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 Jubereq therapy permanently.

Hypocalcemia: Severe symptomatic hypocalcemia and fatal cases have been reported. Correct pre-existing hypocalcemia prior to Jubereq treatment, and fatal cases have been reported. Monitor calcium levels throughout therapy, especially in the first weeks, 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 healthcare provider for symptoms of hypocalcemia.

Increased risk of hypocalcemia has been observed in patients with increasing renal dysfunction, most commonly with worsening CrCl (<30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.

Osteonecrosis of the Jaw (ONJ): ONJ has been reported 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 the incidence of ONJ was higher with longer duration of exposure.

Predisposing factors for developing ONJ include a history of tooth extraction, poor oral hygiene, and use of a dental appliance. Other risk factors include immunosuppressive therapy, use of angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.

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

Patients who are suspected of having or who develop ONJ while on Jubereq 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 Fractures: Atypical femoral fractures have 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.

During Jubereq treatment, advise patients to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain 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 Jubereq therapy should be considered, pending a risk/benefit assessment.

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons: Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in denosumab product-treated patients with giant cell tumor of bone and patients with growing skeletons within one year of treatment discontinuation. Monitor for signs and symptoms of hypercalcemia after treatment discontinuation 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 Jubereq treatment is discontinued, evaluate the patient's risk for vertebral fractures.

Embryo-Fetal Toxicity: Jubereq can cause fetal harm when administered to a pregnant woman. Based on data from animal studies and its mechanism of action, Jubereq is expected to result in adverse reproductive effects.

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

Most Common Adverse Reactions:

• Bone Metastasis from Solid Tumors: Greater than or equal to 25%: fatigue/asthenia, hypophosphatemia, and nausea.
• Multiple Myeloma: Greater than or equal to 10%: diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.
• Giant Cell Tumor of Bone: Greater than or equal to 10%: arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.
• Hypercalcemia of Malignancy: Greater than 20%: nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.

INDICATIONS

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

• Prevention of skeletal-related events in patients with multiple myeloma and in patients with 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 is likely to result in severe morbidity.
• Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Jubereq (denosumab-desu) injection is supplied in a 120 mg/1.7 mL (70 mg/mL) single-dose vial.

About Accord BioPharma

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com.

References:

1. Osvyrti® (denosumab-desu) Prescribing Information. Accord BioPharma.
2. Jubereq® (denosumab-desu) Prescribing Information. Accord BioPharma.
3. Amgen Reports Fourth Quarter and Full Year 2024 Financial Results.
   https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results
4. Accord BioPharma. Data on file.

SOURCE Accord BioPharma

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