In August and September 2025, the US Food and Drug Administration (FDA) approved six denosumab biosimilars, expanding treatment options for patients with bone health issues.
The originator products are Amgen’s Prolia (60 mg/mL injection) and Xgeva (120 mg/mL injection). Prolia is approved for the treatment of bone resorption and postmenopausal osteoporosis and Xgeva is approved for the treatment of bone fractures and neoplasm metastasis [1].
The approved denosumab biosimilars are Shanghai Henlius Biotech and Organon’s Bildyos (denosumab-nxxp) 60 mg/mL injection and Bilprevda (denosumab-nxxp) 120 mg/1.7 mL injection; Hikma Pharmaceuticals’ Enoby (denosumab-qbde) 60 mg/mL injection and Xtrenbo (denosumab-qbde) 120 mg/1.7 mL injection; and Biocon Biologics’ Bosaya (denosumab-kyqq) 60 mg/mL injections for subcutaneous use in a single dose prefilled syringe (PFS), and Aukels (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial.
The biosimilars are approved in two distinct dosages corresponding to their reference products: a 60 mg/mL dose for the Prolia biosimilars and a 120 mg/mL dose for the Xgeva biosimilars.
Key Factors in the FDA's Decision
These approvals were granted following the review of comprehensive data packages that established the biosimilars as highly similar to their reference products, Prolia and Xgeva, with no clinically meaningful differences in safety, purity, and potency.
Among the newly approved agents are Bildyos and Bilprevda (denosumab-nxxp) from Shanghai Henlius and Organon. The approval was supported by structural, functional, and clinical pharmacokinetic data, including a comparative clinical study. In a strategic move to broaden global access, Henlius entered into a license and supply agreement with Organon in 2022, granting the latter exclusive commercialization rights for these biosimilars in all markets outside of China.
Similarly, the FDA approved Enoby and Xtrenbo (both denosumab-qbde), developed through a partnership between Hikma and Richter. Under a December 2021 agreement, Richter was responsible for the development and manufacture of the products, while Hikma handled the FDA registration and holds exclusive commercialization rights in the US. The approval was based on a comprehensive submission of analytical, non-clinical, and clinical data that demonstrated comparable quality, efficacy, safety, and immunogenicity to the reference products.
Another addition to the market is Bosaya (denosumab-kyqq). Clinical data confirmed its comparable quality, safety, and efficacy. In line with its reference product, Prolia, Bosaya is approved with the same Risk Evaluation and Mitigation Strategy (REMS) to inform healthcare providers and patients about the risk of severe hypocalcemia in patients with advanced chronic kidney disease.
These approvals mark a significant step in increasing competition and potentially improving patient access to essential denosumab therapies.
These approvals come after news that in June 2025, the first FDA-approved denosumab biosimilars, Sandoz’s Wyost and Jubbonti were launched [2, 3].
Additionally, these approvals bring the number of denosumab biosimilars that will be available to US patients more in line with European counterparts. By the end of September 2025, the European Medicines Agency had recommended marketing authorization for 21 denosumab biosimilars (10 referencing Xgeva and 11 referencing Prolia) [3], while the FDA had approved only 14 denosumab biosimilars, 7 each referencing Xgeva and Prolia, four with interchangeable designation [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. First denosumab biosimilars approved in Canada and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 20]. Available from:
www.gabionline.net/biosimilars/news/first-denosumab-biosimilars-approved-in-canada-and-the-us
2. GaBI Online - Generics and Biosimilars Initiative. New denosumab and ustekinumab biosimilar launches in US, Canada and Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 20]. Available from: www.gabionline.net/pharma-news/new-denosumab-and-ustekinumab-biosimilar-launches-in-us-canada-and-japan
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 20]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 6]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-US
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