Latest FDA-Approved Biosimilars for Osteoporosis Treatment
In recent years, the landscape of osteoporosis treatment has seen significant evolution, particularly with the introduction of biosimilars. Instead of a single 'new' drug, multiple interchangeable biosimilars for the established medication denosumab (referenced by Prolia) have entered the market following FDA approval. These biosimilars offer new options for patients with osteoporosis at high risk of fracture, increasing access and potentially lowering healthcare costs. Denosumab works by targeting a protein called RANK ligand (RANKL) to reduce bone resorption, the process by which bone is broken down.
Denosumab Biosimilars Approved in 2024
One of the most notable approvals in 2024 was Sandoz's denosumab-bbdz, marketed under the brand names Jubbonti and Wyost. Jubbonti received approval for use in patients with osteoporosis, while Wyost is indicated for cancer-related bone events. This approval marked a significant milestone, as it was the first interchangeable biosimilar for denosumab. An interchangeable biosimilar must meet additional requirements demonstrating it can be substituted for the reference product without compromising safety or efficacy, similar to a generic drug but for biologics.
Key indications for Jubbonti include:
- Postmenopausal women with osteoporosis at high risk for fracture.
- Men with osteoporosis at high risk for fracture.
- Patients with glucocorticoid-induced osteoporosis.
Denosumab Biosimilars Approved in 2025
Following the groundbreaking approval in 2024, 2025 saw a flurry of additional biosimilar approvals, further expanding market options. This included products from Samsung Bioepis, Celltrion, Fresenius, Henlius Biotech, and Biocon Biologics.
- Samsung Bioepis's denosumab-dssb (Ospomyv and Xbryk): Approved in February 2025, these biosimilars reference Prolia and Xgeva, respectively.
- Celltrion's denosumab-bmwo (Stoboclo and Osenvelt): Approved in early March 2025, also referencing Prolia and Xgeva.
- Fresenius Kabi's denosumab-bnht (Conexxence and Bomyntra): Approved in March 2025 and launched in June 2025.
- Shanghai Henlius Biotech's denosumab-nxxp (Bildyos and Bilprevda): Approved in August 2025, referencing Prolia and Xgeva.
- Biocon Biologics' denosumab-kyqq (Bosaya and Aukelso): Approved in September 2025 and granted provisional interchangeability.
This influx of biosimilars provides a more competitive market, which could lead to increased accessibility and lower costs for patients.
Comparison with Romosozumab (Evenity)
It's important to distinguish between recent biosimilar approvals and the last newly developed drug, romosozumab (Evenity), which was approved in 2019. While romosozumab was the last novel biologic approved, recent developments focus on biosimilars for denosumab. Romosozumab, an anti-sclerostin monoclonal antibody, is an anabolic agent that builds bone, whereas denosumab and its biosimilars are antiresorptive agents that slow bone breakdown.
Romosozumab (Evenity) vs. Denosumab (Prolia) and its Biosimilars
| Feature | Romosozumab (Evenity) | Denosumab (Prolia) and Biosimilars |
|---|---|---|
| Mechanism | Inhibits sclerostin, increasing bone formation and decreasing bone resorption. | Inhibits RANK ligand (RANKL), slowing bone breakdown. |
| Usage | Limited to a 12-month course, followed by another osteoporosis drug. | Can be used long-term, although discontinuation may lead to rapid bone loss. |
| Administration | Monthly subcutaneous injection administered by a healthcare provider. | Subcutaneous injection, typically self-administered every six months. |
| Primary Function | Bone-building (anabolic) with an antiresorptive effect. | Slows bone loss (antiresorptive). |
| Target Population | Primarily postmenopausal women at high fracture risk. | Postmenopausal women, men with osteoporosis, and other high-risk populations. |
| Cost and Access | High cost; single-source drug. | Lower cost and increased access due to competition from multiple biosimilars. |
The Importance of Biosimilars
The FDA’s approval of multiple interchangeable denosumab biosimilars is a pivotal development in osteoporosis management. Biosimilars are highly similar versions of an FDA-approved reference biologic product, with no clinically meaningful differences in terms of safety, purity, and potency. Their availability provides clinicians and patients with more affordable options while maintaining a high standard of care. This is especially important for long-term conditions like osteoporosis, where treatment can be costly.
Conclusion
To answer the question, "What is the new FDA approved drug for osteoporosis?", the most recent approvals are several interchangeable biosimilars for denosumab, the reference product for Prolia. These biosimilars, including Jubbonti (2024) and Bosaya (2025), represent the latest developments in expanding treatment options. While the last novel biologic was romosozumab (Evenity) in 2019, the recent biosimilar approvals provide increased access and affordability. Patients should consult their healthcare provider to determine the most suitable medication for their specific needs, considering factors such as fracture risk, medical history, and treatment goals.
Royal Osteoporosis Society: Romosozumab (Evenity) Drug Treatment for Osteoporosis
