FDA approves denosumab biosimilar Ponlimsi

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FDA approves denosumab biosimilar Ponlimsi

Biosimilars/News | Posted 24/04/2026 0 Post your comment

On 30 March 2026, the US Food and Drug Administration (FDA) approved Teva Pharmaceuticals’ Ponlimsi (denosumab-adet), a biosimilar to Amgen’s Prolia and Xgeva (denosumab) [1].

Denosumab is a human monoclonal antibody that binds to RANKL (receptor activator of nuclear factor kappa-Β ligand), a protein essential for the formation, function, and survival of osteoclasts. By inhibiting RANKL, denosumab reduces bone resorption. It is used to treat osteoporosis and bone loss due to cancer, as well as to prevent skeletal-related events in patients with bone metastases [1].

The approval was supported by a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety, and immunogenicity profiles between Ponlimsi (denosumab-adet) and the reference product, Prolia.

Ponlimsi (denosumab-sldn) is approved for all indications of the reference product, including:

treatment of postmenopausal women with osteoporosis at high risk for fracture
treatment to increase bone mass in men with osteoporosis at high risk for fracture
treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
treatment increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

The product is supplied as a 60 mg/mL single-use prefilled syringe for subcutaneous injection.

With this approval, Ponlimsi becomes the latest denosumab biosimilar in Teva’s growing biosimilars portfolio. Teva has announced that a commercial launch is expected in the third quarter of 2026.

By end of December 2025, the FDA had approved a total of 18 denosumab biosimilars [2]. There were no other biosimilars approved by the FDA in March 2026, and there were no biosimilars approved in February 2026.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 24]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us

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