FDA approves Sandoz’s two denosumab biosimilars

[Maxone73]

In case of bone metastasis

pharmaceutical-technology.c...

[MateoBeach]

This is good news. Biosimilar alternatives to Xgeva and Prolia.

"Jubbonti is also approved to augment bone mass in men at high fracture risk due to undergoing androgen deprivation treatment for non-metastatic prostate cancer, and women receiving adjuvant aromatase inhibitor therapy for breast cancer."

Denosumab is underutilized in men with advanced PCa. We are at high risk for skeletal adverse events because of the natural disease progression to bone mets (perhaps in 90% ultimately), and the inevitable effects of ADT. My opinion is to favor early implementation of bone protection rather than waiting until significant osteoporosis and/ or bone metastasis. It can be covered by Medicare if even one site shows osteopenia on DEXA scan. Risk on ONJ is just 2-5% and is lowest if one has good dentition status and care. MB

[Gearhead in reply to MateoBeach]

Yes, good news. But there is much inconsistent information re ONJ risk with denosumab. For example, this* study found that more than 20% of PCa patients receiving denosumab developed ONJ after 5 years.

*Nakai Y, Kanaki T, Yamamoto A, et al. Antiresorptive agent-related osteonecrosis of the jaw in prostate cancer patients with bone metastasis treated with bone-modifying agents. J Bone Miner Metab. 2021;39(2):295–301.