What is Jubbonti (denosumab-bbdz)?
Jubbonti (denosumab-bbdz) is the most recent denosumab biosimilar approved by the FDA for treating postmenopausal osteoporosis in women at high risk for fracture. It is considered a biosimilar to Prolia (denosumab), meaning it is highly similar to the reference product and has no clinically meaningful differences in terms of safety or effectiveness. Its approval and subsequent launch in June 2025 expands the availability of this effective medication, potentially reducing healthcare costs and increasing patient access.
Jubbonti works by inhibiting a protein called RANKL, which is essential for the formation and function of osteoclasts—the cells responsible for breaking down bone. By blocking RANKL, Jubbonti slows bone resorption, leading to an increase in bone mineral density and a reduced risk of fractures. It is administered via a subcutaneous injection once every six months.
Other notable recent osteoporosis drugs
While Jubbonti is the newest denosumab option, other important osteoporosis drugs have been approved in recent years. Romosozumab (Evenity) and other denosumab biosimilars are particularly significant.
-
Romosozumab (Evenity): This is a unique anabolic agent that both increases new bone formation and decreases bone resorption simultaneously. Approved in April 2019, romosozumab is a sclerostin inhibitor that works differently from anti-resorptive drugs like denosumab. It is approved for postmenopausal women at very high fracture risk and is administered as a monthly injection for a limited duration of 12 months.
-
Other denosumab biosimilars: Beyond Jubbonti, several other interchangeable biosimilars for Prolia (denosumab) have gained FDA approval recently, including Stoboclo® and Osenvelt® (February 2025), Conexxence® and Bomyntra® (March 2025), and Bildyos® and Bilprevda® (September 2025). These approvals are aimed at improving affordability and expanding treatment choices.
Anabolic vs. antiresorptive drugs
Osteoporosis treatments fall into two main categories: anabolic and antiresorptive. Anabolic agents build new bone, while antiresorptive agents slow down the breakdown of existing bone.
- Anabolic agents: These are bone-building drugs. Examples include teriparatide (Forteo), abaloparatide (Tymlos), and the dual-acting agent romosozumab (Evenity). They are typically reserved for patients with severe osteoporosis or those who have not responded to other therapies.
- Antiresorptive agents: These are the most common class of osteoporosis drugs. They work by inhibiting the activity of osteoclasts. Examples include bisphosphonates (like alendronate/Fosamax) and denosumab (Prolia and its biosimilars, such as Jubbonti).
Comparison table of recent osteoporosis drugs
| Feature | Jubbonti (denosumab-bbdz) | Romosozumab (Evenity) | Abaloparatide (Tymlos) |
|---|---|---|---|
| Drug Type | Interchangeable biosimilar to Prolia; antiresorptive | Anabolic; dual-acting sclerostin inhibitor | Anabolic; synthetic analog of PTHrP |
| Mechanism | Inhibits RANKL to prevent bone resorption | Builds new bone and decreases bone resorption | Stimulates osteoblastic activity for new bone formation |
| Administration | Subcutaneous injection, once every 6 months | Subcutaneous injection, once monthly for 12 months | Daily subcutaneous injection for up to 2 years |
| FDA Approval | March 2024 (launched June 2025) | April 2019 | April 2017 |
| Who is it for? | Postmenopausal women and men with osteoporosis at high fracture risk | Postmenopausal women with very high fracture risk | Postmenopausal women and men at high fracture risk |
| Common Side Effects | Low blood calcium, muscle/joint pain, headache, fatigue | Joint pain, headache, potential cardiovascular risks | Dizziness, headache, hypercalciuria |
| Follow-up Therapy | Continuous treatment required to maintain effect | Followed by an antiresorptive agent | Followed by an antiresorptive agent |
How to decide on an osteoporosis treatment
Choosing the right osteoporosis drug is a decision that requires careful consideration in consultation with a healthcare provider. The newest drug is not automatically the best for every individual. Factors influencing the choice include the severity of osteoporosis, fracture risk profile, potential side effects, cost, and patient lifestyle.
Your doctor will evaluate your specific situation, possibly using tools like bone mineral density (BMD) testing and fracture risk assessments, to recommend the most appropriate course of action. For instance, while anabolic agents offer rapid bone building, their use is often limited in duration and must be followed by an antiresorptive medication. Conversely, antiresorptive treatments provide a longer-term strategy for maintaining bone density.
Lifestyle changes, such as ensuring adequate calcium and vitamin D intake, engaging in regular weight-bearing exercise, and avoiding smoking and excessive alcohol, are also crucial components of any osteoporosis management plan.
Conclusion
The newest FDA-approved drug for osteoporosis is Jubbonti (denosumab-bbdz), an interchangeable biosimilar to Prolia that launched in the US in June 2025. It works by slowing bone breakdown to reduce fracture risk. While this is the latest entry, other newer therapies like the anabolic agent romosozumab (Evenity) and various denosumab biosimilars offer additional options. These developments provide healthcare professionals with an expanding range of tools to help patients manage osteoporosis and prevent debilitating fractures. However, selecting the best treatment always depends on a personalized assessment of a patient's individual needs and health profile.
