Two new denosumab biosimilars earn FDA approval

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Key takeaways:

The FDA approved denosumab-bmwo for all indications of the reference drugs Prolia and Xgeva.
According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1.

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, according to a press release from Celltrion.

Denosumab-bmwo (Stoboclo/Osenvelt, Celltrion) were approved by the FDA based on findings from multiple phase 3 trials. The trials assessed the efficacy, pharmacodynamics, pharmacokinetics, safety and immunogenicity of biosimilar denosumab compared with the reference medication in a group of postmenopausal women with osteoporosis. According to Celltrion’s release, denosumab-bmwo had equivalent efficacy and pharmacodynamics to the reference medications, with similar pharmacokinetics, safety and immunogenicity profiles.

Stoboclo was approved as a biosimilar referencing Prolia (Amgen). The medication was approved for postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass for men with osteoporosis at high risk for fracture, to treat adults with glucocorticoid-induced osteoporosis, to increase bone mass for men receiving androgen deprivation therapy for nonmetastatic prostate cancer and to increase bone mass for women with a high fracture risk undergoing adjuvant aromatase inhibitor therapy for breast cancer.

Osenvelt was approved as a biosimilar referencing Xgeva (Amgen) and can be prescribed to treat skeletal-related events for patients with multiple myeloma and those with bone metastases from solid tumors, to treat adults and adolescents with a giant cell tumor of bone that is unresectable or when surgical resection could result in severe morbidity and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

“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, PhD, professor of medicine and Protein Research Chair in the biochemistry department of the College of Science, King Saud University, Riyadh, Saudi Arabia and director of the WHO Collaborating Centre for Epidemiology of Musculoskeletal Health and Aging in Liège, Belgium, said in the release. “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 FDA approval follows a confidential settlement reached by Amgen and Celltrion in January. According to a statement from Amgen, the company had filed patent infringement litigation against Celltrion related to the company’s denosumab biosimilars. Amgen’s statement acknowledged that it and Celltrion reached a confidential settlement that will allow Celltrion to launch is denosumab biosimilar products in the U.S. as early as June 1, 2025.

The new approval is the second time in less than a month the FDA has approved new denosumab biosimilars. As Healio previously reported, the FDA approved two versions denosumab-dssb (Samsung Bioepis) in February, with Ospomyv referencing Prolia and Xbryk referencing Xgeva. The FDA approved denosumab-bddz (Wyost/Jubbonti, Sandoz) as the first denosumab biosimilars available in the U.S. in March 2024.