What is Prolia?
Prolia (denosumab) is a monoclonal antibody injection that blocks RANKL, a protein involved in bone breakdown. It treats osteoporosis in postmenopausal women at high fracture risk, increases bone mass in men with osteoporosis, and prevents bone loss from hormone therapy for breast or prostate cancer.[1]
How does Prolia work?
Prolia binds to RANKL, preventing it from activating osteoclasts, the cells that break down bone. This slows bone resorption, increases bone density, and reduces fracture risk in the spine, hip, and other sites.[1][2]
Who makes Prolia and how is it given?
Amgen manufactures Prolia. It's given as a 60 mg subcutaneous injection every six months by a healthcare provider.[1]
What conditions does Prolia treat?
Approved uses include:
- Postmenopausal osteoporosis to cut vertebral, nonvertebral, and hip fracture risk.
- Bone loss in men on testosterone suppression for cancer.
- Glucocorticoid-induced osteoporosis.
Not for osteoporosis in men without hormone therapy or other uses without FDA approval.[1][2]
Common side effects and risks
Back pain, extremity pain, muscle pain, high cholesterol, and bladder infections occur frequently. Serious risks: jaw osteonecrosis, atypical thigh bone fractures, low calcium (hypocalcemia), severe infections, and skin reactions. Pretreatment calcium/vitamin D supplementation is required.[1]
How does Prolia compare to Fosamax or Reclast?
Prolia reduces vertebral fractures more than oral bisphosphonates like Fosamax (alendronate) in head-to-head studies, with similar hip fracture protection but easier dosing (twice-yearly vs. weekly pills). Reclast (zoledronic acid IV) matches Prolia on bone density gains but needs annual infusion. Prolia's effects reverse faster upon stopping.[2][3]
Cost and access
A single Prolia dose costs $1,500–$2,000 without insurance; patient assistance programs from Amgen reduce it for eligible users. Medicare Part B covers injections.[4]
When does Prolia's patent expire?
Core patents on denosumab expired in 2017–2020 in the US, but formulation and method patents extend to 2025–2030. No FDA-approved biosimilars yet; challenges ongoing. Check DrugPatentWatch.com for latest expiry and litigation details.[5]
[1] Prolia Prescribing Information, Amgen, 2023. https://pi.amgen.com/~/media/Project/Amgen/Repository/pi-amgen-com/Prolia/proliapihcpenglish.pdf
[2] FDA Label, Denosumab. https://www.accessdata.fda.gov/drugsatfdadocs/label/2010/125320s0077lbl.pdf
[3] NEJM Study: Black et al., 2010. https://www.nejm.org/doi/full/10.1056/NEJMoa0910607
[4] GoodRx Pricing Data, 2024. https://www.goodrx.com/prolia
[5] DrugPatentWatch.com, Prolia Patents. https://www.drugpatentwatch.com/p/tradename/PROLIA