Teva Pharmaceutical Industries has secured U.S. Food and Drug Administration approval for DEGEVMA, a denosumab biosimilar referencing Amgen’s Xgeva, across all indications of the reference medicine. The approval covers prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treatment of certain patients with giant cell tumor of bone, and hypercalcemia of malignancy that is refractory to bisphosphonate therapy.
DEGEVMA becomes Teva’s second FDA-approved denosumab biosimilar this year following PONLIMSI, which references Prolia and is used across osteoporosis and treatment-related bone-loss indications. Together, the two products give Teva biosimilar versions spanning the separate oncology and osteoporosis uses of denosumab, although both will enter U.S. markets where several competing biosimilars have already been approved.
DEGEVMA matches Xgeva across oncology-related indications and denosumab mechanism
DEGEVMA is approved as a 120 mg/1.7 mL injectable formulation corresponding to the strength used with Xgeva. Its largest potential use is prevention of skeletal-related events in patients with multiple myeloma and patients whose solid tumors have metastasized to bone, where excessive osteoclast activity can contribute to fractures, spinal cord compression and the need for radiation or surgery to bone.
The drug is also approved for adults and skeletally mature adolescents with giant cell tumor of bone when the tumor cannot be surgically removed or when surgery would be expected to cause severe morbidity. A third indication covers hypercalcemia of malignancy in patients whose disease has not adequately responded to bisphosphonate therapy.
Denosumab is a human monoclonal IgG2 antibody targeting receptor activator of nuclear factor kappa B ligand, commonly known as RANKL. Blocking RANKL prevents activation of the RANK receptor and suppresses formation, function and survival of osteoclasts, reducing bone resorption and helping limit cancer-associated bone destruction.
FDA approval was based on the biosimilar regulatory standard rather than an independent demonstration that DEGEVMA provides superior clinical outcomes. Teva submitted analytical, preclinical and clinical evidence showing that the product has no clinically meaningful differences from Xgeva in safety, purity and potency, together with comparable efficacy and immunogenicity.
That distinction is fundamental to interpreting the approval. Biosimilars are not generic copies in the conventional small-molecule sense because biologic medicines are substantially more complex, but FDA approval requires a highly similar biological profile and no clinically meaningful difference from the reference product. The goal is therefore to reproduce the established therapeutic performance of Xgeva rather than demonstrate a new clinical advantage.
Teva now has denosumab biosimilars covering both Xgeva and Prolia indications
DEGEVMA completes the other half of Teva’s U.S. denosumab strategy. The FDA previously approved PONLIMSI, also identified as denosumab-adet, as a biosimilar to Prolia for osteoporosis and several forms of treatment-associated bone loss.
Although Xgeva and Prolia contain the same reference biologic, denosumab, their strengths, dosing schedules and approved uses differ. Xgeva is primarily associated with oncology-related bone disease and is supplied at the higher 120 mg dose, while Prolia uses a 60 mg dose for osteoporosis and other conditions involving elevated fracture risk.
Teva can therefore use DEGEVMA and PONLIMSI to participate across two distinct denosumab markets without relying on a single indication. The company expects to launch both products in the United States in the coming months as part of its broader biosimilar commercialization strategy.
DEGEVMA has already received European authorization, while PONLIMSI has also progressed through European regulatory review and regional commercialization. Teva has positioned biosimilars as one component of its broader strategy to expand beyond traditional generic medicines and build a larger portfolio of complex biologics and innovative therapies.
The approval is clinically relevant because biologics can represent a substantial component of treatment expenditure, particularly in oncology. Biosimilar competition can increase the number of treatment options available to hospitals and payers while creating pressure on pricing, although the magnitude of actual savings depends on contracting, reimbursement, market uptake and competition among manufacturers.
Crowded denosumab biosimilar market may limit the advantage of being newly approved
DEGEVMA does not enter an uncontested U.S. market. The FDA has already approved multiple denosumab biosimilars referencing Xgeva, including Wyost, Xbryk, Osenvelt, Conexxence and several additional products approved during 2025.
That growing field means Teva’s commercial execution may matter more than regulatory differentiation. Hospitals, oncology practices and pharmacy benefit structures can consider factors including acquisition price, contracting terms, payer coverage, supply reliability and manufacturer support when deciding which biosimilar products gain meaningful share.
Some competing denosumab products have also received interchangeable status. FDA-designated interchangeability means the biosimilar meets additional regulatory requirements that can permit substitution for the reference product at the pharmacy level under applicable state laws, although practical relevance varies substantially for physician-administered biologics such as denosumab.
Teva’s release describes DEGEVMA as a biosimilar to Xgeva but does not state that it has received an interchangeable designation. The clinical implication remains that FDA found the product biosimilar to the reference medicine with no clinically meaningful differences, while the absence of a stated interchangeability designation should not be interpreted as evidence of inferior efficacy or safety.
Teva may instead benefit from offering a broader denosumab portfolio through DEGEVMA and PONLIMSI. Supplying biosimilars to both major denosumab reference brands could strengthen contracting opportunities with health systems and payers seeking broader biologics relationships, although the competitive benefit will depend on pricing and market access after launch.
Safety profile remains consistent with the established risks of denosumab treatment
Because DEGEVMA is designed to reproduce Xgeva’s clinical performance, it also carries the major safety considerations associated with denosumab. Severe symptomatic hypocalcemia can occur, and patients with pre-existing hypocalcemia should have the condition corrected before treatment begins. Calcium levels require monitoring, particularly during the first weeks of therapy and among patients with severe renal impairment.
Osteonecrosis of the jaw is another important risk, particularly with prolonged exposure and in patients with factors such as prior tooth extraction, poor oral hygiene, immunosuppressive therapy or corticosteroid use. Preventive dental evaluation is recommended before treatment, while invasive dental procedures should generally be avoided during therapy where possible.
Additional warnings include atypical femoral fractures, hypercalcemia after treatment discontinuation in certain patients, multiple vertebral fractures following discontinuation and potential embryo-fetal toxicity. Patients receiving DEGEVMA should not simultaneously receive another denosumab-containing product.
These warnings largely reflect the known pharmacology and clinical experience of the reference therapy rather than new safety signals specific to DEGEVMA. For clinicians, the practical decision is therefore less about choosing a different biological mechanism and more about whether a biosimilar can provide the same established therapeutic role with improved accessibility or lower cost.
DEGEVMA approval expands Teva’s biosimilar portfolio as U.S. launch approaches
Teva has been steadily expanding its biosimilar pipeline alongside its traditional generics business and newer branded medicines. Its portfolio includes approved and regulatory-stage biosimilars targeting several major biologic franchises, with additional candidates referencing products such as Xolair, Simponi, Eylea and Entyvio at different stages of development or review.
DEGEVMA is the company’s second FDA-approved biosimilar of 2026 following PONLIMSI, giving Teva two related products derived from the same denosumab development platform. The company describes that progress as part of its broader “Pivot to Growth” strategy, which aims to combine its large generics infrastructure with a larger contribution from innovative medicines and biosimilars.
The approval itself establishes clinical comparability rather than superiority over Xgeva, and the crowded denosumab biosimilar field makes commercial uptake the next important measure of success. Teva now needs to translate its regulatory progress into formulary access, competitive pricing and reliable supply as DEGEVMA and PONLIMSI move toward U.S. launch.
For patients and healthcare systems, the significance is broader competition around an established biologic used across oncology and bone disease. For Teva, the milestone creates a complete U.S. denosumab biosimilar portfolio and another test of whether its expanding biosimilars business can become a meaningful contributor to long-term growth.
