FDA Approves Wave of Denosumab Biosimilars, Expanding Access to Osteoporosis and Cancer Treatments
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The Food and Drug Administration has approved a new generation of denosumab biosimilars, offering more affordable treatment options for patients battling osteoporosis and cancer-related bone loss. The approvals, announced in late December 2025, signal a significant step toward increasing access to these life-changing biologics.
Lowering Costs with Biosimilar Competition
According to a company release, the approvals include biosimilars referencing both Prolia and Xgeva, established treatments manufactured by Amgen. Amneal Pharmaceuticals, in collaboration with mAbxience, received approval for two of these biosimilars: Boncresa and Oziltus (denosumab-mobz). “Biosimilars are the next wave of affordable medicines in the US, expanding access to life-changing biologics for millions of patients,” stated Chirag and Chintu Patel, co-CEOs of Amneal Pharmaceuticals.
This wave of approvals extends beyond Amneal’s products. Additional biosimilars referencing denosumab include Xbryk and Ospomyv (Samsung Bioepis Co), Stoboclo and Osenvelt (Celltrion USA), Conexxence and Bomyntra (Fresenius Kabi), Bildyos and Bilprevda (Shanghai Henlius Biotech, Organon), Bosaya and Aukelso (Biocon Biologics Ltd.), and Osvyrti and Jubereq (Accord BioPharma). Several of these—Stoboclo, Osenvelt, Conexxence, Bomyntra, Aukelso, and Bosaya—have also received an interchangeability designation, potentially allowing pharmacists to substitute them for the reference product without a physician’s approval, pending further regulatory steps in October 2025.
Understanding the Treatments and Their Uses
Boncresa, mirroring Prolia, is indicated for a range of conditions related to bone health, including:
- Postmenopausal women with osteoporosis at high fracture risk.
- Men with osteoporosis needing to increase bone mass.
- Individuals with glucocorticoid-induced osteoporosis and elevated fracture risk.
- Men undergoing androgen deprivation therapy for prostate cancer with associated fracture risk.
- Women receiving aromatase inhibitor therapy for breast cancer and at high fracture risk.
It’s crucial to note that Prolia carries a boxed warning regarding severe hypocalcemia in patients with advanced chronic kidney disease, a potentially life-threatening condition. Healthcare providers must rule out pregnancy before initiating treatment. Reported adverse events in postmenopausal women include back pain, musculoskeletal pain, hypercholesterolemia, and cystitis, while men have reported back pain, joint pain, and nasopharyngitis.
Similarly, Oziltus, like Xgeva, is indicated for:
- Preventing skeletal-related events in patients with multiple myeloma and bone metastases.
- Treating adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or poses a high risk of severe complications from surgery.
- Managing hypercalcemia of malignancy unresponsive to bisphosphonate therapy.
The most serious reported adverse event associated with Xgeva is dyspnea, alongside fatigue, nausea, and hypophosphatemia. Patients with bone metastases commonly experience fatigue and nausea, while those with multiple myeloma may encounter gastrointestinal issues and anemia. Pain, nausea, and headache are frequently reported in cases of giant cell tumor and hypercalcemia of malignancy. The manufacturer emphasizes the risk of fetal harm and recommends effective contraception for women of reproductive potential.
Administration and Ongoing Monitoring
Both Boncresa and Oziltus, like their reference products, require administration by a healthcare professional. Patients should also be advised to monitor their serum calcium levels and seek immediate medical attention if they experience signs of an allergic reaction.
Jurgen Van Broeck, CEO of mAbxience, highlighted the significance of these approvals, stating, “The FDA approval of our denosumab biosimilars marks a significant milestone… It reflects the strength of our scientific capabilities, our commitment to the highest quality standards, and our shared ambition to expand access to affordable, high-quality biologic medicines in the United States.”
These approvals represent a substantial advancement in providing more accessible and affordable treatment options for millions of Americans facing osteoporosis and cancer-related bone complications.
