Two Celltrion Denosumab Biosimilars Now Available in US

Celltrion USA, the New Jersey-headquartered United States subsidiary of South Korea-based Celltrion, announced on July 7, 2025 that two biosimilars it has developed for denosumab are now commercially available in the US (1).

Biosimilars specifically referencing Amgen products

The biosimilars, marketed under the names Stoboclo and Osenvelt (both denosumab-bmwo), reference the brand names Prolia and Xgeva, respectively (1). Both of those medicines are made by Amgen, which Thomas Nusbickel, chief commercial officer of Celltrion USA, acknowledged in a company press release.

"We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars," Nusbickel said (1). "We are proud to introduce our denosumab biosimilars to the US market, offering patients and healthcare professionals a valuable alternative treatment option. Building on our strong heritage in biosimilars, Celltrion remains committed to being a trusted partner for both patients and physicians, while contributing to the overall sustainability of healthcare systems."

Multiple indications for each drug

Stoboclo, in 60 mg/mL injection, has been approved for indications encompassing several conditions among groups at high risk for fracture, including osteoporosis in postmenopausal women and that which is glucocorticoid-induced in both men and women; and to increase bone mass in men with osteoporosis or who are receiving androgen deprivation therapy for nonmetastatic prostate cancer, or in women receiving adjuvant aromatase inhibitor therapy for breast cancer (1).

Osenvelt, available in 120 mg/1.7 mL (70 mg/mL) injection, is indicated for the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, and treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is either unresectable or for whom surgical resection would result in severe morbidity, as well as treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy (1).

Other recent Celltrion activity

The launch of the two Celltrion biosimilars in the US came on the same day that two other biosimilars of denosumab, Biocon Biologics’ Vevzuo and Evfraxy, were granted marketing authorization in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (2). In addition, also on July 7, Theramex’s Eladynos (abaloparatide) was recommended by the Scottish Medicines Consortium for treatment of osteoporosis in postmenopausal women who are at very high risk of fracture (3).

Celltrion has seen some of its other biosimilar candidates also advance in 2025. In February, the European Commission granted marketing authorization for Avtozma (CT-P47), referencing Roche’s RoActemra (tocilizumab), for all indications including treatment of moderate to severely active rheumatoid arthritis, both active systemic and polyarticular juvenile idiopathic arthritis, and giant cell arteritis (4).

In March 2025, FDA approved Omlyclo (omalizumab-igec) as the first interchangeable biosimilar to Genentech and Novartis’ Xolair (omalizumab), for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis, reduction of reactions to food, and chronic spontaneous urticaria (5). Finally in April, Celltrion was granted interchangeable designation by FDA for its adalimumab-aaty, under the brand name Yuflyma, a biosimilar to AbbVie’s adalimumab offering, Humira, as a high-concentration (100mg/mL) and citrate-free formulation for treating multiple inflammatory indications (6).

References

1. Celltrion. Celltrion USA Announces US Launch of Denosumab Biosimilars, Stoboclo and Osenvelt (denosumab-bmwo). Press Release. July 8, 2025.
2. Biocon Biologics. Biocon Biologics Receives MHRA UK Approval for Vevzuo and Evfraxy, Denosumab Biosimilars. Press Release. July 7, 2025.
3. Theramex. SMC Recommends Eladynos (abaloparatide) for Treating Osteoporosis in Postmenopausal Women. Press Release. July 7, 2025.
4. Celltrion. Celltrion Receives EC Approval for Avtozma (CT-P47), a Biosimilar to RoActemra (tocilizumab). Press Release. Feb. 24, 2025.
5. CDER Division of Drug Information. FDA Approves First Interchangeable Biosimilar to Xolair (omalizumab). Press Release. March 10, 2025.
6. Celltrion. US FDA Grants Interchangeable Designation to Yuflyma (adalimumab-aaty), Celltrion's Biosimilar to Humira (adalimumab). Press Release. April 14, 2025.