Denosumab-Adet Gains FDA Approval for All Indications of Denosumab

The FDA has approved denosumab-adet (Ponlimsi) as a biosimilar to denosumab (Prolia) for all indications of the reference product.¹

The FDA approval of Ponlimsi was backed by a totality of evidence, including analytical and clinical data showing similar efficacy, safety, and immunogenicity profiles of the biosimilar compared with reference denosumab. Ponlimsi is approved for all indications of the reference product, including the treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, the management of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for the management of nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for the management of breast cancer.

“Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we’re building a highly competitive portfolio,” Steffen Nock, PhD, head of biosimilars R&D and chief science officer at Teva, stated in a news release. “With a strong early-stage pipeline and a suite of advancing programs, we see significant potential to address patient needs and fuel Teva’s long-term growth.”

What is the regulatory history of Ponlimsi?

In November 2025, the European Commission granted marketing authorization to Ponlimsi following a positive opinion from the Committee for Medicinal Products for Human Use earlier in 2025.² The regulatory decision indicated the biosimilar for the management of osteoporosis in postmenopausal women and men who are at increased risk of fractures, the treatment of bone loss associated with hormone ablation in men with prostate cancer who are at increased risk of fractures, and the treatment of bone loss in adult patients receiving long-term treatment with systemic glucocorticoids.

What is the safety profile of Ponlimsi?

Ponlimsi carries a safety warning for severe hypocalcemia in patients with advanced kidney disease.¹ Patients with advanced chronic kidney disease (defined by an eGFR < 30 mL/min/1.73 m²), including dialysis-dependent patients, have a greater risk of severe hypocalcemia following denosumab product administration. Moreover, the presence of chronic kidney disease-mineral bone disorder significantly increases the risk of hypocalcemia in these patients. Prior to beginning treatment with Ponlimsi, patients with advanced chronic kidney disease should be evaluated for the presence of chronic kidney disease-mineral bone disorder; patients in this group who receive Ponlimsi should be supervised with a health care provide with expertise in the diagnosis and management of chronic kidney disease-mineral bone disorder.

Ponlimsi is contraindicated in patients with hypocalcemia, pregnant women, and patients with hypersensitivity to denosumab products. The biosimilar also carries warnings and precautions for mineral metabolism changes, concomitant use of drug products with same active ingredient, osteonecrosis of the jaw, atypical subtrochanteric and diaphyseal femoral fractures, multiple vertebral fractures following discontinuation of treatment, serious infections, dermatologic adverse reactions, musculoskeletal pain, suppression of bone turnover, and hypercalcemia in pediatric patients with osteogenesis imperfecta.

“The FDA approval of Ponlimsi is a significant milestone that showcases our robust clinical, analytical, operational and regulatory expertise,” Yolanda Tibbe, global head of biosimilars at Teva, added in the news release. “To receive US FDA approval of Ponlimsi…truly underscores the strength of our expanding global biosimilar portfolio and reaffirms our commitment to expand treatment options for patients.”

References

1. Teva gains biosimilar momentum with U.S. FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab). News release. Teva. March 30, 2026. Accessed March 30, 2026. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Gains-Biosimilar-Momentum-with-U-S--FDA-Approval-of-PONLIMSI-denosumab-adet-and-Dual-Filing-Acceptance-for-Biosimilar-Candidate-to-Xolair-omalizumab/default.aspx
2. Teva receives European Commission approvals for Ponlimsi (denosumab) biosimilar to Prolia and Degevma (denosumab) biosimilar to Xgeva. News release. Teva. November 25, 2025. Accessed March 30, 2026. https://www.tevausa.com/news-and-media/press-releases/teva-receives-european-commission-approvals-for-ponlimsi-denosumab-biosimilar-to-prolia-and-degevma-/