FDA Approves Celltrion’s Denosumab Biosimilars Stoboclo and Osenvelt

Celltrion has achieved a significant milestone in its pharmaceutical endeavors, as the US Food and Drug Administration (FDA) has granted approval for two of its biosimilar drugs, Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo). These approvals are based on their reference to Amgen's established bone disease treatments, Prolia and Xgeva. Such advancements are expected to provide more accessible healthcare options for patients across various indications related to bone health and cancer-related conditions.

Stoboclo has been sanctioned for multiple therapeutic uses. It is designed to address osteoporosis in postmenopausal women who are at a heightened risk of fractures. This approval includes increasing bone mass in men suffering from osteoporosis under similar risk conditions. Furthermore, Stoboclo is authorized for treating glucocorticoid-induced osteoporosis in both men and women facing high fracture risks. It also serves as a treatment to enhance bone density in men undergoing androgen deprivation therapy for prostate cancer that is nonmetastatic. Additionally, women receiving adjuvant aromatase inhibitor therapy for breast cancer can use Stoboclo to boost their bone mass.

Osenvelt has been approved for several crucial indications as well. It is intended to help prevent skeletal-related complications in patients who have multiple myeloma or have bone metastases stemming from solid tumors. Moreover, it is authorized for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone, especially when the tumor cannot be surgically removed or if such resection would lead to severe health issues. Osenvelt also targets hypercalcemia of malignancy that does not respond to bisphosphonate therapy.

The concept of biosimilars, as defined by the FDA, refers to biological medicines that closely resemble a previously approved treatment. This similarity ensures that patients can expect the same level of safety and efficacy from the biosimilar as they would from the original product. The introduction of biosimilars like Stoboclo and Osenvelt holds the promise of reduced healthcare costs for patients.

Supporting the FDA's decision on these biosimilars are extensive clinical trials, including phase 3 studies involving postmenopausal women with osteoporosis. These trials demonstrated that Celltrion’s biosimilars possess efficacy and pharmacodynamics on par with the original denosumab. Furthermore, they showcased similar pharmacokinetics, alongside comparable safety and immunogenicity profiles.

Thomas Nusbickel, Celltrion USA's chief commercial officer, expressed optimism about these developments. He remarked that the approval of Stoboclo and Osenvelt marks significant progress in the company's mission to offer cost-effective, high-quality treatments for conditions associated with osteoporosis and cancer-related skeletal events. He emphasized the importance of providing therapeutic options that can profoundly impact patient care and improve quality of life.

With the anticipated availability of Stoboclo and Osenvelt in the United States set for June 2025, Celltrion is poised to enhance treatment accessibility and affordability for individuals facing bone health challenges and cancer-related complications. This strategic move underscores Celltrion's commitment to advancing healthcare solutions that address critical unmet medical needs.