Biocon Announces U.S. Commercial Launch of Bosaya™ and Aukelso™, Denosumab Biosimilars
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Bosaya™ and Aukelso™ (both denosumab-kyqq products) now available in
the United States , followingU.S. FDA approval inSeptember 2025 with an interchangeable designation - Potential benefit to the estimated 10 million adults with osteoporosis and over 330,000 patients annually with bone metastasis, a common complication of advanced cancer
Shreehas Tambe, CEO & Managing Director,
Denosumab products play a critical role in bone health, treating osteoporosis and bone complications associated with cancer. In 2024, denosumab products generated approximately
Both biosimilars will be available in the most common presentations:
- Bosaya™ (biosimilar to Prolia®): 60 mg/mL injection for subcutaneous use in a prefilled syringe.
- Aukelso™ (biosimilar to Xgeva®): 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial.
Epidemiology:
Osteoporosis is a chronic disease that weakens bones, making them fragile and more prone to fracture. In
Bone metastases are a common complication of advanced cancer, affecting more than 330,000 patients annually in
Giant cell tumor of bone (GCTB) is a rare, locally aggressive benign tumor that primarily affects young adults. While noncancerous, it can cause severe pain, fractures, and disability.
About BOSAYA1 and AUKELSO2:
Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). RANKL is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, denosumab reduces bone breakdown, increasing bone mass and strength.
About BOSAYA (denosumab-kyqq)
WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
See full prescribing information for complete boxed warning.
- Patients with advanced chronic kidney disease 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.
Prior to initiating BOSAYA in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with BOSAYA in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD.
Warnings and Precautions:
- Pre-existing hypocalcemia must be corrected before initiating BOSAYA. May worsen, especially in patients with renal impairment. Adequately supplement all patients with calcium and vitamin D. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor serum calcium.
- Patients receiving BOSAYA should not receive other denosumab products concomitantly.
- Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs.
- Osteonecrosis of the jaw has been reported with denosumab products. Monitor for symptoms.
- Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture.
- Multiple vertebral fractures have been reported following treatment discontinuation. Patients should be transitioned to another antiresorptive agent if BOSAYA is discontinued.
- Serious infections including skin infections may occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis.
- Dermatologic reactions such as, dermatitis, rashes, and eczema have been reported. Consider discontinuing BOSAYA if severe symptoms develop.
- Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop.
- Significant suppression of bone turnover has been demonstrated. Monitor for consequences of bone over-suppression.
Adverse reactions:
- Postmenopausal osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.
- Male osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, arthralgia, and nasopharyngitis.
- Glucocorticoid-induced osteoporosis: Most common adverse reactions (> 3% and more common than active-control group) were: back pain, hypertension, bronchitis, and headache.
- Bone loss due to hormone ablation for cancer: Most common adverse reactions (≥ 10% and more common than placebo) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
Use in Specific Populations:
- Pregnant women and females of reproductive potential: Denosumab products may cause fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of BOSAYA.
- Pediatric patients: BOSAYA is not approved for use in pediatric patients.
- Renal impairment: No dose adjustment is necessary in patients with renal impairment. Patients with advanced chronic kidney disease (eGFR<30 mL/min/1.73 m2), including dialysis-dependent patients, are at greater risk of severe hypocalcemia. The presence of underlying chronic kidney disease-mineral bone disorder markedly increases the risk of hypocalcemia.
About AUKELSO (denosumab-kyqq)
Warnings and Precautions:
- Patients receiving AUKELSO should not receive other denosumab products concomitantly.
- Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs.
- Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating AUKELSO. 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 AUKELSO. Monitor for symptoms. Avoid invasive dental procedures during treatment with AUKELSO.
- Evaluate patients with thigh or groin pain to rule out a femoral fracture.
- Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons, patients should be monitored for signs and symptoms of hypercalcemia, and manage as clinically appropriate.
- Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation, when AUKELSO treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.
- Embryo-Fetal Toxicity can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception.
Adverse Reactions:
- Bone Metastasis from Solid Tumors: Most common adverse reactions (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea.
- Multiple Myeloma: Most common adverse reactions (≥ 10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.
- Giant Cell Tumor of Bone: Most common adverse reactions (≥ 10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.
- Hypercalcemia of Malignancy: Most common adverse reactions (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.
Use in Specific Populations:
- Pediatric patients: Recommended only for treatment of skeletally mature adolescents with giant cell tumor of bone.
- Renal impairment: Patients with creatinine clearance less than 30 mL/min or receiving dialysis are at risk for hypocalcemia. Adequately supplement with calcium and vitamin D.
Please refer to the full Patient Information for detailed safety information. To report SUSPECTED ADVERSE REACTIONS, contact
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BOSAYA. Prescribing information.
2AUKELSO. Prescribing information.
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5 Hernandez RK, Adhia A, Wade SW, O’Connor E, Arellano J, Francis K, Alvrtsyan H, Million RP, Liede A. Prevalence of bone metastases and bone-targeting agent use among solid tumor patients in
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About
Forward-Looking Statements:
This press release may include statements of future expectations and other forward-looking statements based on management’s current expectations and beliefs concerning future developments and their potential effects upon
Bosaya™ and Aukelso™ are trademarks of
All other trademarks, registered or unregistered, are the property of their respective owners.
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