Teva Completes Denosumab Biosimilar Pair With FDA Nod for Degevma

The FDA has approved denosumab-adet (Degevma; Teva Pharmaceutical Industries), a biosimilar to Xgeva (denosumab; Amgen), across all indications of the reference product, Teva announced September 28, 2026.1

Degevma is indicated to prevent bone complications in adults with advanced cancer that has spread to the bone, to treat adults and skeletally mature adolescents with giant cell tumor of bone, and to treat hypercalcemia of malignancy.

Degevma Rounds Out Teva's Denosumab Biosimilar Portfolio

Degevma is Teva's second FDA-approved biosimilar of 2026. It follows the March approval of denosumab-adet (Ponlimsi), a biosimilar to Prolia (denosumab; Amgen) for postmenopausal osteoporosis and the reference product's other indications. Together, the 2 products give Teva a denosumab biosimilar portfolio spanning both oncology-related bone disease and osteoporosis care.1,2

The approval was based on a totality of evidence, including analytical and clinical data demonstrating an efficacy, safety, and immunogenicity profile similar to that of Xgeva, with no clinically meaningful differences in safety, purity, and potency. Like its reference product, Degevma is a human monoclonal antibody that binds to RANKL, a protein essential to the formation, function, and survival of osteoclasts. By inhibiting RANKL, it decreases bone resorption and cancer-induced bone destruction. Degevma will be available as a 120-mg/1.7-mL solution for injection in a vial, and Teva anticipates launching both Degevma and Ponlimsi in the US in the coming months.1

With this approval, 10 companies now hold FDA approval for denosumab biosimilar pairs referencing both Xgeva and Prolia. Each company's pair shares a single nonproprietary name; Ponlimsi and Degevma, for example, are both denosumab-adet.

Denosumab Biosimilar Value Hinges on Price and Payer Access

Degevma's indications center on cancer-related bone disease. One of the first economic evaluations of a denosumab biosimilar, however, focused on osteoporosis, the indication of the Prolia-referencing products. That cost-utility analysis found that biosimilar denosumab was likely to be cost-effective against 4 bisphosphonates for women with postmenopausal osteoporosis at high fracture risk, at a willingness-to-pay threshold of $150,000 per quality-adjusted life-year (QALY). The margin was thinnest against zoledronic acid, with an incremental cost-effectiveness ratio of $144,995 per QALY gained and cost-effectiveness in just 55.4% of simulations.

At a $100,000 threshold, only the comparison with risedronate held up, while alendronate and ibandronate narrowly missed it. The model assumed the biosimilar's price at 80% of reference denosumab's cost, a hypothetical figure because no US price was available at the time, and the results were sensitive to it.

More than 2 million osteoporosis-related fractures occur annually in the US, and direct and indirect costs are projected to climb from $57.0 billion in 2018 to more than $95.2 billion by 2040.3

Sandoz's denosumab-bbdz (Jubbonti), the first FDA-approved denosumab biosimilar, was approved in March 2024 and launched in June 2025. Sandoz positioned it as a lower-cost option intended to expand patient access. Whether lower prices lead to broader access will ultimately be up to payers, said Edward Li, PharmD, corresponding author of the analysis and head of health economics and outcomes research at Sandoz, when he discussed the findings in an interview with The Center for Biosimilars®.4

"The question is no longer whether the biologic works but whether the economic rationale for limiting access remains the same once biosimilar competition enters the market," he said. "Ultimately, payers will decide whether lower costs warrant broader access, but those decisions should be informed by an updated understanding of the therapy's value in the current marketplace."3

Li added that demonstrating cost-effectiveness does not automatically translate into adoption. For payers, he said, the key question is whether lower costs lead to changes in coverage policies and utilization management requirements, and patients benefit only if that improved value shows up as fewer access barriers and broader access to treatment.

"Even if cost barriers come down, there is still work to do to identify appropriate patients, initiate treatment, and keep them on therapy," Li explained. "Ultimately, improving patient access will require both payer and provider stakeholders to recognize how the value proposition has changed with biosimilar competition."

Degevma adds another option to an increasingly crowded denosumab market, though Teva framed its purpose around patients.

"The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine," Thomas Rainey, senior vice president of US Biosimilars at Teva, said in the news release.1

References

1. Teva continues biosimilar momentum with U.S. FDA approval of DEGEVMA (denosumab-adet), a biosimilar to Xgeva (denosumab). News release. Teva Pharmaceutical Industries. September 28, 2026. Accessed September 29, 2026. https://www.tevapharm.com/news-and-media/latest-news/teva-continues-biosimilar-momentum-with-u.s.-fda-approval-of-degevma-denosumab-adet-a-biosimilar-to-x
2. McCrear S. FDA approves Teva biosimilar for denosumab in osteoporosis. The Center for Biosimilars. March 31, 2026. Accessed September 29, 2026. https://www.centerforbiosimilars.com/view/fda-approves-teva-biosimilar-for-denosumab-in-osteoporosis
3. Jeremias S. Biosimilar denosumab shows cost-effectiveness over bisphosphonates in PMO. The Center for Biosimilars. August 4, 2026. Accessed September 29, 2026. https://www.centerforbiosimilars.com/view/biosimilar-denosumab-shows-cost-effectiveness-over-bisphosphonates-in-pmo
4. McCrear S, Li E. Biosimilar denosumab could reshape access, costs in osteoporosis care: Edward Li, PharmD. The Center for Biosimilars. September 1, 2026. Accessed September 29, 2026. https://www.centerforbiosimilars.com/view/biosimilar-denosumab-could-reshape-access-costs-in-osteoporosis-care-edward-li-pharmd