#Jersey City #Celltrion #STOBOCLO #OSENVELT

Celltrion's New Biosimilars Approved by the FDA

In a significant advancement for patient care, Celltrion, a biopharmaceutical leader, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), both referencing the established products PROLIA® and XGEVA®. This approval underlines Celltrion's commitment to providing affordable yet high-quality treatment solutions in areas like osteoporosis and cancer-related bone disease.

Expanding Treatment Options

The newly approved biosimilars are now authorized for all the indications associated with their reference products. STOBOCLO is specifically designed for patients at high risk for fractures due to osteoporosis, while OSENVELT focuses on preventing skeletal-related complications in patients with conditions such as multiple myeloma and solid tumor bone metastases. With the FDA's endorsement, these biosimilars will offer considerable relief to patients facing dire healthcare challenges, enhancing access to crucial treatments.

Clinical Evidence and Approval Process

The FDA's endorsement was based on substantial clinical data demonstrating the effectiveness and safety of these biosimilars. The evidence included results from Phase III clinical trials, particularly conducted on postmenopausal women suffering from osteoporosis. Findings indicated that STOBOCLO exhibited efficacy and pharmacodynamics on par with the reference denosumab, with comparable pharmacokinetics and safety profiles.

According to Thomas Nusbickel, the Chief Commercial Officer at Celltrion USA, this approval represents a significant milestone towards addressing unmet medical needs in treating osteoporosis and cancer-related skeletal issues.