Teva’s DEGEVMA (denosumab-adet) gains FDA approval as a biosimilar to Xgeva, expanding the company’s U.S. denosumab biosimilar portfolio.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved DEGEVMA™ (denosumab-adet) as a biosimilar to Xgeva® (denosumab). The approval covers the indications of the reference product and represents Teva’s second FDA-approved biosimilar in 2026.
DEGEVMA Approved for Multiple Oncology Indications
DEGEVMA is approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. It is also indicated for the treatment of adults and skeletally mature adolescents aged 12 years and older with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.
For the pediatric population, the approval is specifically limited to skeletally mature adolescents, with the reference-product labeling describing this population as adolescents aged 12 to 16 years who have reached skeletal maturity. Age alone does not establish eligibility for this indication.
DEGEVMA is also indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
The approval, together with Teva’s previously approved PONLIMSI™ (denosumab-adet), establishes the company’s U.S. denosumab biosimilar portfolio across the indications of Xgeva and Prolia®, respectively.
Clinical and Analytical Evidence Supporting Approval
The FDA approval was based on a totality-of-evidence approach, incorporating analytical and clinical data. Teva reported that the submitted evidence demonstrated comparable quality, safety and efficacy between DEGEVMA and the reference product, with no clinically meaningful differences in safety, purity or potency.
The data also supported similar efficacy, safety and immunogenicity profiles between DEGEVMA and Xgeva.
About DEGEVMA
DEGEVMA contains denosumab, a human monoclonal IgG2 antibody that targets receptor activator of nuclear factor kappa-B ligand (RANKL). RANKL regulates the formation, function and survival of osteoclasts, which are responsible for bone resorption.
By binding RANKL and preventing its interaction with RANK, denosumab reduces bone resorption and cancer-induced bone destruction.
DEGEVMA will be available as a 120 mg/1.7 mL solution for injection in a vial.
Safety Profile
Pre-existing hypocalcemia must be corrected before initiating DEGEVMA. Severe symptomatic hypocalcemia, including fatal cases, has been reported.
The risk is particularly important in patients with advanced chronic kidney disease, including those with CKD stage 4 or 5 and patients receiving dialysis. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. Before initiating treatment in patients with advanced CKD, evaluation for CKD-MBD is recommended, and treatment should be supervised by a healthcare professional with expertise in its diagnosis and management.
Calcium levels should be monitored during treatment, particularly during the initial weeks, with calcium, magnesium and vitamin D administered as appropriate.
DEGEVMA is contraindicated in patients with clinically significant hypersensitivity to DEGEVMA or denosumab products. Patients receiving DEGEVMA should not receive other denosumab products.
Other important warnings include osteonecrosis of the jaw (ONJ), atypical subtrochanteric and diaphyseal femoral fractures, hypercalcemia following treatment discontinuation in patients with GCTB or growing skeletons, and multiple vertebral fractures following discontinuation.
An oral examination and preventive dental care are recommended before treatment, while patients should report new or unusual thigh, hip or groin pain.
Denosumab products may cause embryo-fetal harm based on animal data and their mechanism of action. Females of reproductive potential should use effective contraception during treatment with DEGEVMA and for at least five months after the last dose.
Adverse Reactions
In patients with bone metastases from solid tumors, the most common adverse reactions reported with DEGEVMA were fatigue/asthenia, hypophosphatemia and nausea, with dyspnea reported as the most common serious adverse reaction.
In patients with multiple myeloma, commonly reported adverse reactions included diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash and headache. Osteonecrosis of the jaw was the most common serious adverse reaction in this population.
Availability
Teva expects to launch DEGEVMA and PONLIMSI in the United States in the coming months.
DEGEVMA is also approved in the European Union, where the biosimilar received authorization in November 2025.
The FDA approval adds DEGEVMA to Teva’s U.S. denosumab biosimilar portfolio, providing a biosimilar to Xgeva for its approved oncology indications while complementing PONLIMSI, which references Prolia.
Reference
Teva Continues Biosimilar Momentum with U.S. FDA Approval of DEGEVMA™ (denosumab-adet), a Biosimilar to Xgeva® (denosumab), Teva, 28 September 2026
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.
