For years, Prolia (denosumab) has been a significant treatment for osteoporosis, a condition characterized by weakened bones. However, recent shifts in the pharmaceutical landscape have introduced new choices for patients and clinicians. The main 'replacements' for Prolia are FDA-approved biosimilars that contain the identical active ingredient, and therapeutic alternatives like Evenity (romosozumab), which works through a different mechanism.
The Rise of Prolia Biosimilars
On March 5, 2024, the U.S. Food and Drug Administration (FDA) approved Jubbonti (denosumab-bbdz) as the first interchangeable biosimilar for Prolia. A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an already FDA-approved reference product, in this case, Prolia. An interchangeable biosimilar can even be substituted for the reference product at the pharmacy level, depending on state laws.
What are Biosimilars?
Unlike generic drugs, which are exact chemical replicas of non-biologic medications, biosimilars are made from living organisms and are structurally complex. The rigorous FDA approval process ensures that biosimilars are just as safe and effective as the original drug. The emergence of biosimilars like Jubbonti is expected to increase access to treatment and potentially lower costs for healthcare systems and patients.
Impact on Patients
For patients switching from Prolia to Jubbonti, there is no change in administration. Both are given as a subcutaneous injection by a healthcare professional. The safety and effectiveness are considered equivalent, meaning patients can expect the same results. Additional biosimilars for denosumab, such as Ospomyv, have also been approved, further expanding options.
Evenity (Romosozumab) as an Alternative
While biosimilars are essentially direct substitutes for Prolia, Evenity (romosozumab-aqqg) represents a different class of medication and is a powerful alternative for certain high-risk patients. The key distinction lies in its mechanism of action and treatment duration.
A Unique Dual-Action Mechanism
Evenity is a monoclonal antibody that has a unique dual effect: it both increases bone formation and decreases bone resorption (the process of breaking down bone tissue). In contrast, Prolia is primarily an antiresorptive agent, meaning it only slows down bone breakdown. This dual-action approach makes Evenity particularly effective for rapidly increasing bone mineral density.
A Short-Term Treatment Option
Evenity is prescribed for a limited duration, after which another osteoporosis medication, often a bisphosphonate or Prolia (denosumab), is used to maintain the bone density gains. This is different from Prolia, which is typically used for long-term treatment.
Cardiovascular Risk
Evenity carries a boxed warning regarding the potential for increased risk of heart attack, stroke, and cardiovascular death. Therefore, it is generally not recommended for patients who have experienced a heart attack or stroke within the past year or have significant risk factors. Prolia does not carry this specific cardiovascular risk warning, though it does carry risks such as severe hypocalcemia, particularly in patients with advanced chronic kidney disease.
Other Established Alternatives
Besides denosumab biosimilars and Evenity, other long-standing osteoporosis treatments remain available, particularly for patients who cannot tolerate biologic therapies.
- Bisphosphonates: These are often first-line treatments and include oral options like alendronate (Fosamax) and risedronate (Actonel), as well as intravenous infusion options like zoledronic acid (Reclast).
- Parathyroid Hormone (PTH) Analogs: Anabolic drugs like teriparatide (Forteo) and abaloparatide (Tymlos) stimulate new bone formation, and may be used sequentially with antiresorptive agents.
- Selective Estrogen Receptor Modulators (SERMs): Raloxifene (Evista) is a treatment option for postmenopausal women that helps slow bone loss.
Choosing the Right Prolia Alternative
Selecting the best medication is a decision that requires careful consideration between a patient and their healthcare provider. It depends on several factors, including fracture risk level, underlying medical conditions, treatment duration goals, and cost. The following table provides a high-level comparison of Prolia, its biosimilar Jubbonti, and the alternative Evenity.
Comparison: Prolia vs. Jubbonti vs. Evenity
| Feature | Prolia (Denosumab) | Jubbonti (Denosumab-bbdz) | Evenity (Romosozumab) |
|---|---|---|---|
| Active Ingredient | Denosumab | Denosumab-bbdz | Romosozumab |
| Mechanism of Action | Inhibits bone breakdown (antiresorptive) | Inhibits bone breakdown (antiresorptive) | Increases bone formation & decreases breakdown (dual-action) |
| Duration | Long-term use recommended | Long-term use recommended | Limited duration, followed by another therapy |
| Administration | Subcutaneous injection | Subcutaneous injection | Subcutaneous injections |
| Cost | Brand-name, potentially higher cost | Biosimilar, potentially lower cost | Brand-name, potentially higher cost |
| Boxed Warning | Severe hypocalcemia in advanced kidney disease | Severe hypocalcemia in advanced kidney disease | Increased risk of heart attack, stroke, and cardiovascular death |
The Future of Osteoporosis Management
With biosimilars now entering the market, patients have access to equivalent and potentially more affordable versions of denosumab. At the same time, specialized therapies like Evenity offer powerful bone-building capabilities for a defined period. This dynamic landscape means that personalized medicine is more crucial than ever in osteoporosis treatment.
Ultimately, the question of what drug is replacing Prolia has a two-pronged answer. Biosimilars like Jubbonti are direct replacements, and alternatives such as Evenity offer a different, but highly effective, therapeutic path. Patient-centered care, guided by thorough medical evaluation, will determine the most suitable option for each individual.
For more information on the FDA approval of denosumab biosimilars, you can visit the FDA's official press release on Jubbonti and Wyost.
