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news.The US Food and Drug Administration (FDA) has approved Celltrion’s Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), the biosimilars referencing Amgen’s Prolia and Xgeva, respectively.
The injections have gained approval for multiple indications in the US. Credit: Diana Polekhina/Shutterstock.
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This approval covers all indications of the reference products and the biosimilars are anticipated to be available by June 2025 in the country as per the settlement agreement with Amgen.
The agency’s decision is supported by clinical evidence, along with outcomes from Phase III trials in postmenopausal women with osteoporosis.
The studies aimed to assess the pharmacodynamics, immunogenicity, pharmacokinetics, efficacy, and safety of CT-P41 compared to reference denosumab.
Celltrion USA chief commercial officer Thomas Nusbickel said: “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.
“Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives. We are committed to continuous innovation to meet these goals leveraging our experience and successful track record with biosimilar and novel biologics.”
Stoboclo 60 mg/mL injection has gained approval for multiple indications in the US.
These include treatment for postmenopausal women with osteoporosis at high risk for fracture, individuals with glucocorticoid-induced osteoporosis, men with osteoporosis at high fracture risk and those receiving androgen deprivation therapy for nonmetastatic prostate cancer.
It is also intended for women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer, among others.
The European Medicines Agency (EMA) also approved Stoboclo last month.
Osenvelt 120 mg/1.7mL, on the other hand, is indicated for the prevention of skeletal-related events in individuals with multiple myeloma and bone metastases from solid tumours.
Like Stoboclo, Osenvelt received EMA approval last month.
