Celltrion USA Launches New Denosumab Biosimilars: STOBOCLO® and OSENVELT®

Celltrion USA has officially introduced two new biosimilars to the U.S. market: STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), both referencing the widely recognized treatments, PROLIA® and XGEVA® respectively. This announcement marks a significant advancement in the availability of cost-effective biologic medicines for diverse patient populations in the United States.

Overview of the New Biosimilars

STOBOCLO® (denosumab-bmwo)

STOBOCLO is now available as a 60 mg/mL injection, specifically approved to meet the needs of various patient groups. It is indicated for treating postmenopausal women with osteoporosis who are at high risk for fractures. Additionally, it helps increase bone mass in men with similar conditions, treats glucocorticoid-induced osteoporosis in both men and women, and enhances bone mass in men undergoing androgen deprivation therapy for nonmetastatic prostate cancer. Furthermore, it also benefits women receiving adjuvant aromatase inhibitor therapy for breast cancer, ensuring a wider reach to those affected by these serious conditions.

OSENVELT® (denosumab-bmwo)

On the other hand, OSENVELT, presented as a 120 mg/1.7 mL (70 mg/mL) injection, is aimed at preventing skeletal-related events in patients suffering from multiple myeloma and those with bone metastases from solid tumors. It’s also indicated for treating adults and skeletally mature adolescents with unresectable giant cell tumor of bone or those for whom surgical resection poses high risks. Additionally, OSENVELT is beneficial for treating hypercalcemia of malignancy that is refractory to bisphosphonate therapy.

Strategic Significance and Future Plans

Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, commented on the strategic importance of these launches, emphasizing the aim to provide patients and healthcare professionals with valuable and effective treatment alternatives. The introduction of these biosimilars is in line with Celltrion's broader mission to ensure accessible and innovative healthcare solutions.

To further support these products, Celltrion has implemented comprehensive patient support programs, including the Celltrion CONNECT® Patient Support Program and the Celltrion CARES™ Co-pay Assistance Program. Uninsured individuals might even qualify to receive these treatments at no cost, thereby enhancing accessibility to essential therapies.

Celltrion USA's dedication to developing quality biologics contributes significantly to patient care, particularly in areas including immunology, oncology, gastroenterology, allergy, and endocrinology. As part of the company’s expansive vision, these biosimilars are positioned to enhance patient treatment pathways significantly.

Important Safety Information

While the launch is a step forward, Celltrion also underscores the importance of educating patients and healthcare professionals about potential risks associated with these treatments. For instance, severe hypocalcemia can occur in patients with advanced kidney disease receiving denosumab; thus, monitoring and assessing patient risk factors before and during treatment is crucial. This safety information stands as a reminder of the evolving landscape of pharmaceuticals and the continuous need for healthcare provider vigilance.

Conclusion

The launch of STOBOCLO and OSENVELT represents a noteworthy development in the biopharmaceutical sector, promising enhanced treatment options for patients across the country. As Celltrion continues to expand its portfolio within the biosimilar space, the company remains committed to improving patient outcomes by marrying affordability with cutting-edge medical solutions. For further details on these biosimilars and to explore available support programs, visit www.CelltrionConnect.com or www.CelltrionCares.com.