About The Trial
Trial Name: A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
ClinicalTrials.gov ID: NCT04757376
Sponsor: Celltrion
Completion Date: November 2023
FDA Approves Denosumab-Bmwo as Biosimilar to Prolia, Xgeva
Denosumab-Bmwo is approved for all indications of the respective reference products, including osteoporosis and high-risk of fracture due to chemotherapy.
The FDA approved denosumab-bmwo (Stoboclo, CT-P41) and denosumab-bmwo (Osenvelt), referencing denosumab as Prolia and Xgeva, respectively, for the indications of both reference products.1
The new biosimilars are expected to be available in June 2025. | Image Credit: Aquir | stock.adobe.com
Stoboclo is indicated for postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporotic for fracture or in men with high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, for glucocorticoid-induced osteoporosis, and for increasing bone mass in women at high risk of fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer.
Osenvelt is approved for prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with giant cell bone tumors that are unresectable or where surgery is likely to result in morbidity, and treatment of hypercalcemia due to malignancy refractory to bisphosphonate therapy.1
Denosumab is 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 osteoporosis patients," Jean-Yves Reginster, MD, MPH, PhD, professor of medicine at the College of Science at King Saud University, said in the news release.1 "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 denosumab product with a clinically proven track record in quality and safety is a valuable addition for my patients."
The approval was based on clinical evidence from a phase 3 clinical trial (NCT04757376) that included postmenopausal women with osteoporosis. Investigators evaluated the efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of the biosimilar. In addition to the biosimilar and active comparator of Prolia, all individuals received daily supplementation of at least 1000 mg of calcium and at least 400 IU of vitamin D.
The primary outcome included percent change from baseline in lumbar spine bone mineral density at week 52. Secondary end points included change from baseline in lumbar spine, total hip, and femoral neck at week 52 and week 28, incidence of new vertebral, nonvertebral, and hip fractures, and number of individuals with at least 1 anti-drug antibody and neutralizing antibodies after the first study drug administration up to week 52 and from week 52 to week 78.2
Investigators found that equivalence was demonstrated for the biosimilar and the reference product, specifically for the efficacy and pharmacodynamic end points. The mean percent change from baseline in lumbar spine at week 52 was –0.139 for the full analysis set. The secondary end points for efficacy, pharmacokinetics, and safety were also comparable up to week 78, including in the transition period.3
Furthermore, safety was similar in each group, with treatment-emergent adverse events (TEAEs) experienced in 75.7% of the biosimilar group and 70.2% in the reference product group. Serious TEAEs were experienced in 7 and 10 patients, respectively. The most frequently reported TEAE was COVID-19 as well as upper respiratory tract infections for patients in both groups.3
"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," Thomas Nusbickel, chief commercial officer at Celltrion USA, said in a news release.1 "Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives."
The new biosimilars are expected to be available in June 2025. Earlier in February 2024, the FDA approved another biosimilar for Prolia and Xgeva, denosumab-dssb (Ospomyv, Xbryk). The first biosimilar denosumab-bbdz (Wyost/Jubbonti) was approved in 2024, which was also granted interchangeability status.4
READ MORE: Biosimilar Resource Center
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REFERENCES
1. Celltrion receives US FDA approval for Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) biosimilars referencing Prolia and Xgeva. News release. Celltrion. March 3, 2025. Accessed March 4, 2025. https://prnmedia.prnewswire.com/news-releases/celltrion-receives-us-fda-approval-for-stoboclo-denosumab-bmwo-and-osenvelt-denosumab-bmwo-biosimilars-referencing-prolia-and-xgeva-302390957.html
2. A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis. ClinicalTrials.gov identification: NCT04757376. Updated June 14, 2024. Accessed March 4, 2025. https://clinicaltrials.gov/study/NCT04757376
3. Reginster JY, Czerwinski E, Wilk K, et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024;35(11):1919-1930. doi:10.1007/s00198-024-07161-x
4. Gallagher A. FDA Approves Denosumab-Dssb as Biosimilar for Prolia, Xgeva. Drug Topics. February 17, 2025. Accessed March 4, 2025. https://www.drugtopics.com/view/fda-approves-denosumab-dssb-as-biosimilar-for-prolia-xgeva
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