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October 28, 2025

New Osteoporosis Biosimilar Approved

The FDA has approved Enoby™ (denosumab-qdbe) injections as a biosimilar to Prolia® (denosumab) to increase bone mass in those at high risk of fractures.

As the workforce grows older, and as entities such as the WCRI report on the frequency and impacts that degenerative conditions have on claims, awareness of these conditions and the therapies that address them becomes increasingly important.

Enoby is indicated to increase bone mass in:

  • Postmenopausal women with osteoporosis at high risk of fracture
  • Men with osteoporosis at high risk of fracture
  • Men and women with glucocorticoid-induced osteoporosis at high risk for fracture
  • Men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • In women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

Enoby should be administered by a healthcare provider, and it is contraindicated in those with hypocalcemia, in those who are pregnant, and in those with a known hypersensitivity to denosumab. Adverse reactions include back pain, pain in extremity, hypercholesterolemia (increased LDL or bad cholesterol), musculoskeletal pain, cystitis (bladder infection), pancreatitis, arthralgia (joint pain), nasopharyngitis (cold), hypertension, bronchitis, and headache.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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