Celltrion Receives Approval for Denosumab Biosimilars STOBOCLO® and OSENVELT®
Tuesday, March 04, 2025
Celltrion has received approval from the U.S. Food and Drug Administration (FDA) for its denosumab biosimilars, STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo).
STOBOCLO® (denosumab-bmwo) is a receptor activator of NF-κB ligand (RANKL) inhibitor referencing PROLIA®. The FDA has approved the 60 mg/mL injection following a review of clinical data confirming its therapeutic equivalence.
In the U.S., STOBOCLO is approved for treating postmenopausal women with osteoporosis at high risk of fractures, increasing bone mass in men with osteoporosis at high risk of fractures, and treating glucocorticoid-induced osteoporosis in men and women at high risk of fractures.
It is also approved for increasing bone mass in men receiving androgen deprivation therapy for non-metastatic prostate cancer and women receiving adjuvant aromatase inhibitor therapy for breast cancer.
The European Medicines Agency (EMA) granted approval for STOBOCLO in February 2025.
These biosimilars reference the osteoporosis and bone-related cancer treatments PROLIA® (denosumab) and XGEVA® (denosumab) and have been approved for all indications of the reference products.
The FDA's decision is based on clinical evidence, including Phase III trials in postmenopausal women with osteoporosis. The studies assessed efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity.
The results confirmed that CT-P41 demonstrated equivalent efficacy and pharmacodynamics to reference denosumab, along with similar pharmacokinetics, safety, and immunogenicity.
Denosumab is widely used to protect bone health in patients with osteoporosis and those undergoing cancer treatments. For postmenopausal osteoporosis patients, it is often a long-term therapy.
Biosimilars have expanded across various therapeutic areas, including immunology, oncology, and ophthalmology, offering potential cost savings and improved access to treatment.
As part of a settlement agreement with Amgen Inc., STOBOCLO and OSENVELT are expected to be available in the U.S. from June 2025.
Source: celltrion.com
