Medmonitor

An up-to-date timeline of U.S. Food and Drug Administration (FDA) approvals that could potentially impact workers' compensation. These include new drug and indication approvals, new dosages or formulations of existing products, and generics introduced to the market. Click through the interactive timeline below, or select the comprehensive list view.
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Medication Type: Degenerative Conditions

Ponlimsi™ (denosumab-adet) injection

Approval Date: Mar 2026

Note: New Drug

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

Boncresa (denosumab-mobz) injection

Approval Date: Dec 2025

Note: Biosimilar

A biosimilar to Prolia® (denosumab), this drug is a RANKL inhibitor indicated for the treatment of osteoporosis in postmenopausal women with high risk of fracture, to increase bone mass in men with osteoporosis at a high risk for fracture, for the treatment of glucocorticoid-induced osteoporosis in men and women with high risk of fracture, and more

Enoby™ (denosumab-qdbe) injection

Approval Date: Sep 2025

Note: Biosimilar

A biosimilar to Prolia®, this drug is a RANKL inhibitor indicated for the treatment of osteoporosis in postmenopausal women with high risk of fracture, to increase bone mass in men with osteoporosis at a high risk for fracture, for the treatment of glucocorticoid-induced osteoporosis in men and women with high risk of fracture, and more

Medication Name

Approval Date

Category

Description

Ponlimsi™ (denosumab-adet) injection

Mar 2026

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

Note: New Drug

Boncresa (denosumab-mobz) injection

Dec 2025

A biosimilar to Prolia® (denosumab), this drug is a RANKL inhibitor indicated for the treatment of osteoporosis in postmenopausal women with high risk of fracture, to increase bone mass in men with osteoporosis at a high risk for fracture, for the treatment of glucocorticoid-induced osteoporosis in men and women with high risk of fracture, and more

Note: Biosimilar

Enoby™ (denosumab-qdbe) injection

Sep 2025

A biosimilar to Prolia®, this drug is a RANKL inhibitor indicated for the treatment of osteoporosis in postmenopausal women with high risk of fracture, to increase bone mass in men with osteoporosis at a high risk for fracture, for the treatment of glucocorticoid-induced osteoporosis in men and women with high risk of fracture, and more

Note: Biosimilar
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