U.S. License Holder:

Teva

Date of License:

March-30-2026

FDA-Approved Indications

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PONLIMSI (denosumab-adet) is a RANK ligand (RANKL) inhibitor indicated for treatment:

Of postmenopausal women with osteoporosis at high risk for fracture;

To increase bone mass in men with osteoporosis at high risk for fracture;

Of glucocorticoid-induced osteoporosis in men and women at high risk for fracture;

To increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer;

To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Approved Foreign Follow-On Biologics / Biosimilars

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Biosimilars Approved In The E.U.

Ponlimsi / Degevma (Teva) (November-2025)