FDA approves denosumab biosimilar Degevma

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FDA approves denosumab biosimilar Degevma

Biosimilares/Novedades | Posted 03/11/2026 0 Post your comment

On 25 September 2026, the US Food and Drug Administration (FDA) approved Teva Pharmaceuticals’ Degevma (denosumab-adet), a biosimilar to Amgen’s Xgeva (denosumab) [1].

The two Teva denosumab biosimilar approvals sharing the same nonproprietary name—denosumab-adet—but bearing distinct brand names: Ponlimsi and Degevma. The distinction lies in the reference products they emulate and the patient populations they serve.

Ponlimsi was approved on 27 March 2026 as a biosimilar to Amgen’s Prolia [1]. It is supplied as a 60 mg/mL prefilled syringe and covers osteoporosis-related indications, including postmenopausal osteoporosis and bone loss associated with certain cancer therapies.

Degevma is approved as a biosimilar to Xgeva. It is formulated as a 120 mg/1.7 mL single-dose vial for oncology-related bone disease, including prevention of skeletal-related events in advanced cancer, giant cell tumour of bone, and hypercalcemia of malignancy.

Both Ponlimsi and Degevma were approved in Europe on 17 November 2026 [2].

Degevma is indicated for the prevention of bone complications in adults with advanced cancer that has spread to the bone, for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone and for the treatment of hypercalcemia of malignancy.

The shared ’-adet’ suffix follows FDA’s four-letter biologics naming convention for pharmacovigilance. The separate brand names reflect the clinical and commercial segmentation inherited from the reference products: Prolia and Xgeva contain identical denosumab but are approved for different indications and dosing presentations.

Regarding the reasons for the six-month gap between the two approvals: Teva did not explain this in its press release. However, FDA approval documents show that Degevma (BLA 761481) was received on 29 September 2025, while Ponlimsi was reviewed under a separate BLA (761385). Teva's disclosed Phase 3 trial (NCT04729621) used Prolia as the comparator in postmenopausal osteoporosis, while Degevma’s approval rests on a totality-of-evidence package including analytical similarity and extrapolation, so the two applications differ in data focus. The timing of facility inspections and FDA information requests may also affect approval pace, but these internal review details are not public.

Teva has stated it anticipates launching both products in the U.S. in the coming months, giving the company biosimilar coverage across both Prolia and Xgeva indications.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves denosumab biosimilar Ponlimsi [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Nov 3]. Available from: www.gabionline.net/biosimilars/news/fda-approves-denosumab-biosimilar-ponlimsi
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for nine biosimilars [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Nov 3]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-nine-biosimilars

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