FDA grants approval to Samsung Bioepis’ Ospomyv and Xbryk, expanding access to biosimilar treatments for osteoporosis and cancer-related bone loss

The U.S. Food and Drug Administration (FDA) has approved Ospomyv™ and Xbryk™, two biosimilars developed by Samsung Bioepis Co., Ltd., referencing Prolia and Xgeva, respectively. This regulatory milestone marks a significant step in expanding the availability of biosimilar treatments for osteoporosis and cancer-related bone loss, providing an alternative to high-cost biologics.

With this approval, Samsung Bioepis introduces its first endocrinology biosimilar to the U.S. market while continuing to expand its biosimilar portfolio across multiple therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. Additionally, the FDA has granted a provisional interchangeability designation for both Ospomyv and Xbryk, which could further enhance accessibility for patients by allowing pharmacy-level substitution.

Biosimilar Approval Expands Treatment Options for Osteoporosis and Bone Complications in Cancer Patients

Ospomyv has been approved for the treatment of osteoporosis in postmenopausal women and men at high risk of fractures, offering a biosimilar alternative to Prolia. The approval also covers patients receiving hormone-related cancer therapies, such as androgen deprivation therapy for nonmetastatic prostate cancer and aromatase inhibitor therapy for breast cancer, both of which are associated with bone mass loss. Patients diagnosed with glucocorticoid-induced osteoporosis are also included in the approved indications.

Xbryk, which references Xgeva, is now authorized for the prevention of skeletal-related events in patients with multiple myeloma and solid tumor bone metastases. It is also indicated for treatment of giant cell tumor of bone in cases where surgery is not viable or poses severe risks and for managing hypercalcemia of malignancy that is unresponsive to bisphosphonate therapy.

These approvals signal a major advancement in the biosimilar market, allowing more patients to access cost-effective osteoporosis treatment and cancer-related bone loss therapies without compromising efficacy or safety.

The Role of Biosimilars in Reducing Treatment Costs and Expanding Patient Access

Biosimilars are designed to provide therapeutically equivalent alternatives to branded biologics at a lower cost, helping to reduce financial barriers for patients and healthcare systems. The introduction of Ospomyv and Xbryk is expected to contribute to a more competitive biosimilar market, particularly in the areas of osteoporosis care and cancer-related bone disease management.

Industry experts emphasize that the adoption of biosimilars plays a crucial role in lowering prescription drug costs and expanding treatment access. By offering a biosimilar alternative to Prolia and Xgeva, Samsung Bioepis aims to increase affordability for patients who rely on these medications for bone health and cancer-related skeletal complications.

Clinical Data Supporting the Approval of Ospomyv and Xbryk

The FDA’s approval of Ospomyv and Xbryk is based on extensive analytical, non-clinical, and clinical data, demonstrating that these biosimilars meet rigorous regulatory standards for equivalency with their reference products.

Clinical studies included a Phase 1 pharmacokinetics (PK) trial, which confirmed PK equivalence between SB16 (denosumab-dssb), EU-sourced denosumab, and US-sourced denosumab in healthy male participants. The trial measured bioavailability and drug concentration levels, showing comparable results between the biosimilar and the reference biologics.

Additionally, a Phase 3 randomized, double-blind trial assessed the efficacy, safety, immunogenicity, and pharmacodynamics (PD) profiles of SB16 in postmenopausal osteoporosis patients. The study demonstrated comparable bone mineral density (BMD) improvements over 12 months, with follow-up data extending to 18 months confirming that switching from the reference product to SB16 did not impact clinical outcomes.

These findings validate the clinical equivalence of Ospomyv and Xbryk, reinforcing their potential to provide effective osteoporosis treatment and skeletal event prevention in cancer patients.

Market Impact: Samsung Bioepis Expands Its Biosimilar Portfolio in the U.S.

The approval of Ospomyv and Xbryk marks the ninth and tenth FDA-approved biosimilars for Samsung Bioepis, further strengthening its position in the competitive biosimilar landscape. With a strong pipeline spanning multiple therapeutic areas, the company is actively broadening its biosimilar offerings to address the growing demand for cost-effective biologic alternatives.

In the osteoporosis treatment market, which has been dominated by Prolia, and the oncology-related bone health sector, where Xgeva has maintained a leading position, the introduction of these biosimilars is expected to drive greater market competition. Increased competition may lead to price reductions, further enhancing patient accessibility to essential treatments.

As biosimilar adoption increases, pharmaceutical pricing strategies and healthcare provider acceptance will play key roles in shaping the success of these alternatives. Analysts predict that interchangeable biosimilars, such as Ospomyv and Xbryk (pending full interchangeability approval), could see strong uptake among insurers and healthcare systems seeking to manage drug expenditures.

Safety Considerations for Ospomyv and Xbryk

While Ospomyv and Xbryk offer therapeutic benefits comparable to their reference biologics, healthcare providers must remain mindful of key safety considerations. Patients with severe hypocalcemia, advanced kidney disease, or a history of osteonecrosis of the jaw (ONJ) require careful monitoring.

The most notable risks associated with denosumab biosimilars include:

• Severe hypocalcemia, particularly in patients with chronic kidney disease.
• Osteonecrosis of the jaw (ONJ), necessitating dental evaluations before and during treatment.
• Atypical femoral fractures, requiring monitoring for thigh or groin pain in long-term users.
• Multiple vertebral fractures following treatment discontinuation, emphasizing the need for careful transition planning when stopping therapy.

Healthcare professionals should evaluate individual patient risk factors and implement appropriate monitoring strategies to ensure safe treatment with Ospomyv and Xbryk.

The Future of Biosimilars in Osteoporosis and Cancer Treatment

The FDA approval of Ospomyv and Xbryk underscores the growing role of biosimilars in addressing osteoporosis and cancer-related skeletal conditions. As biosimilar competition intensifies, insurers and healthcare providers are expected to prioritize cost-effective alternatives to high-priced biologics, potentially increasing biosimilar adoption rates in the U.S.

Looking ahead, the success of Ospomyv and Xbryk in the market will depend on healthcare provider acceptance, insurance coverage policies, and long-term clinical performance. The expanding biosimilar landscape is poised to drive greater affordability and accessibility, reinforcing the importance of biosimilar innovation in modern healthcare.