The Food and Drug Administration (FDA) has approved Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab) and Xgeva (denosumab), to protect bone health in patients undergoing cancer treatment.
The approval was announced in a news release from biopharmaceutical company Celltrion. According to the news release, Stoboclo and Osenvelt are expected to be available in the United States in June 2025.
Biosimilar drugs, according to the National Cancer Institute, are very much like another biological drug, referred to as the reference drug, that has already been approved by the FDA. Additionally, these drugs must be shown to be as safe as, work as well as and work in a similar way as the reference drug.
Among patients with cancer, Xgeva is approved to treat giant cell tumors of the bone that cannot be removed by surgery and hypercalcemia of malignancy that got worse after treatment with bisphosphonates, according to the National Cancer Institute. It is also approved to prevent broken bones or other bone problems caused by multiple myeloma, or by solid tumors that have spread to the bone, according to the National Cancer Institute.
Prolia is approved to increase bone mass among adults with a high risk of breaking bones and is used among patients with breast cancer receiving aromatase inhibitor therapy and patients with prostate cancer receiving androgen deprivation therapy, the National Cancer Institute noted.
The drug is also being studied in the treatment of other conditions and types of cancer, according to the National Cancer Institute.
Glossary:
Hypercalcemia: High levels of calcium in the blood.
Bisphosphonates: Medications used to treat bone conditions.
Aromatase inhibitor therapy: Treatments that lower estrogen levels in the body.
Androgen deprivation therapy: Treatment to lower the level of androgens in the body.
Pharmacodynamics: The study of the biochemical and physiological effects of drugs and the mechanisms of their actions.
Pharmacokinetics: The activity of drugs in the body over a period of time.
Immunogenicity: The ability of a substance that contains antigens to cause the body to make an immune response against that substance.
“[Prolia and Xgeva are] used to improve or protect bone health in patients with osteoporosis or those undergoing various cancer treatments and as a therapy for a lifetime for postmenopausal [patients with osteoporosis],” said Jean-Yves Reginster, Professor of Medicine, Protein Research Chair, Biochemistry Department, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia and Director WHO Collaborating Centre for Epidemiology of Musculoskeletal Health and Aging, Liège, Belgium. "Biosimilars have expanded into new therapeutic areas such as immunology, oncology and ophthalmology, as they continue to offer significant cost-saving potential while expanding patient access. Having a [Prolia and Xgeva] product with a clinically proven track record in quality and safety is a valuable addition for my patients."
The approval, according to the news release, is based on data including results of phase 3 clinical trials among postmenopausal women with osteoporosis intended to evaluate the effectiveness, pharmacodynamics, pharmacokinetics, safety and immunogenicity of Stoboclo and Osenvelt in reference to Prolia and Xgeva, with study results demonstrating that the former had equivalent effectiveness and pharmacodynamics to the latter, with similar pharmacokinetics and comparable safety and immunogenicity.
"The approval of Stoboclo and Osenvelt is another step forward in our efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, in the news release. "Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives."
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