FDA Approves Teva's DEGEVMA, a Denosumab Biosimilar to Xgeva, Across All Reference Indications
核心洞察
The FDA approved Teva's DEGEVMA (搜索) (denosumab-adet (搜索)) as a biosimilar to Xgeva across all reference indications, including bone complications from advanced cancer.
Approval was based on a totality of evidence showing no clinically meaningful differences from Xgeva in safety, purity and potency.
DEGEVMA (搜索) is Teva's second FDA-approved biosimilar of 2026, following PONLIMSI (搜索) in March, forming a denosumab portfolio spanning Xgeva and Prolia indications.
Teva Pharmaceutical Industries announced on Sept. 28, 2026 that the U.S. Food and Drug Administration has approved DEGEVMA (搜索) (denosumab-adet (搜索)) as a biosimilar to Xgeva (denosumab). The approval covers all indications of the reference product: prevention of bone complications in adults with advanced cancer that has spread to the bone, treatment of adults and skeletally mature adolescents with giant cell tumor of bone (搜索), and treatment of hypercalcemia of malignancy (搜索).
DEGEVMA (搜索) is a human monoclonal IgG2 antibody that binds with high affinity and specificity to RANKL (搜索), a protein essential for the formation, function and survival of osteoclasts, the cells responsible for bone resorption. By preventing the interaction between RANKL and RANK, denosumab decreases bone resorption in cortical and trabecular bone and reduces cancer-induced bone destruction. The product will be supplied as a 120mg/1.7mL solution for injection in a vial.
Evidence Base and Regulatory Review
The FDA approval was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety and immunogenicity to Xgeva. Teva said the comprehensive data package submitted to the agency showed no clinically meaningful differences from the reference product in terms of safety, purity and potency. The company describes the supporting package as comprising comprehensive analytical, preclinical and clinical data demonstrating comparable quality, safety and efficacy.
DEGEVMA (搜索) was approved in the European Union on Nov. 18, 2025, and is currently approved in the EU.
A Two-Product Denosumab Portfolio
The DEGEVMA (搜索) approval is Teva's second FDA-approved biosimilar in 2026. PONLIMSI (搜索) (denosumab-adet (搜索)) was approved by the FDA in March 2026. Together, the two products establish a U.S. denosumab biosimilar portfolio spanning the indications of both Xgeva and Prolia (denosumab), giving healthcare professionals and patients expanded access to biologic treatment options in oncology-related bone disease and osteoporosis (搜索) care.
Teva anticipates launching DEGEVMA (搜索) and PONLIMSI (搜索) in the U.S. in the coming months, in line with its broader biosimilar commercialization strategy.
"Our R&D mission is grounded in a clear commitment: translating complex biologic science into high-quality treatment options that address patient needs," said Rob Cook, Head of Global Technical Development & Generics R&D at Teva. "The approval of DEGEVMA (搜索) reflects the scientific, clinical and regulatory expertise behind our in-house biosimilars capabilities and our continued focus on expanding access to important biologic medicines."
Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, framed the approval in terms of patient access. "The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine," he said. "The approval of DEGEVMA (搜索) is a powerful example of Teva's Pivot to Growth strategy in action because it represents an important step in expanding treatment options for patients and supporting healthcare systems with a high-quality biosimilar."
Teva noted that biologics such as denosumab represent a significant portion of healthcare expenditures, particularly in oncology, and that biosimilar introduction is critical to driving down systemic healthcare costs while broadening patient access to complex medications.
Indications in Detail
Under the approved labeling, DEGEVMA (搜索) is indicated for the prevention of skeletal-related events in patients with multiple myeloma (搜索) and in patients with bone metastases from solid tumors. It is also indicated for adults and skeletally mature adolescents with giant cell tumor of bone (搜索) that is unresectable or where surgical resection is likely to result in severe morbidity, and for hypercalcemia of malignancy (搜索) refractory to bisphosphonate therapy.
Safety Profile
Pre-existing hypocalcemia (搜索) must be corrected before initiating therapy. DEGEVMA (搜索) is contraindicated in patients with known clinically significant hypersensitivity to DEGEVMA or denosumab products, and patients receiving it should not receive other denosumab products.
Clinically significant hypersensitivity, including anaphylaxis, has been reported, with reactions that may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus and urticaria. An anaphylactic or other clinically significant allergic reaction requires appropriate therapy and permanent discontinuation of DEGEVMA (搜索).
DEGEVMA (搜索) can cause severe symptomatic hypocalcemia (搜索), and fatal cases have been reported. Calcium levels should be monitored throughout therapy, especially in the first weeks of treatment, with calcium, magnesium and vitamin D administered as necessary. Concomitant use of calcimimetics and other drugs that lower calcium levels may worsen hypocalcemia risk. An increased risk of hypocalcemia has been observed in clinical trials in patients with increasing renal dysfunction, most commonly severe dysfunction (creatinine clearance less than 30 mL/min and/or on dialysis), and with inadequate or no calcium supplementation.
Osteonecrosis of the jaw (搜索) has been reported in patients receiving DEGEVMA (搜索), manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or gingival erosion. In cancer trials, the incidence of ONJ was higher with longer duration of exposure. Risk factors include a history of tooth extraction, poor oral hygiene, use of a dental appliance, immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes and gingival infections. An oral examination and appropriate preventive dentistry are recommended before initiation and periodically during therapy, and invasive dental procedures should be avoided during treatment.
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with DEGEVMA (搜索), most commonly with minimal or no trauma, and may be bilateral. Patients should be advised to report new or unusual thigh, hip or groin pain, and those presenting with such pain should be evaluated to rule out an incomplete femur fracture, with assessment of the contralateral limb.
Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported after treatment discontinuation in DEGEVMA (搜索)-treated patients with giant cell tumor of bone (搜索) and in patients with growing skeletons; monitoring for signs and symptoms is advised within the first year after discontinuation. Multiple vertebral fractures have also been reported following discontinuation of denosumab products, with higher risk in patients who have risk factors for or a history of osteoporosis (搜索) or prior fractures.
Based on animal data and its mechanism of action, denosumab products can cause fetal harm when administered to a pregnant woman. Pregnant women and females of reproductive potential should be advised that exposure during pregnancy or within 5 months before conception can result in fetal harm.
The most common adverse reactions in patients with bone metastases from solid tumors were fatigue/asthenia, hypophosphatemia and nausea, with dyspnea the most common serious side effect. In patients with multiple myeloma (搜索), the most common adverse reactions were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia (搜索), upper respiratory tract infection, rash and headache, with osteonecrosis of the jaw (搜索) the most common serious side effect.