Celltrion USA Launches Denosumab Biosimilars STOBOCLO® and OSENVELT®

Celltrion USA officially announced the launch of its denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), in the United States on July 7, 2025. These products are intended as cost-effective alternatives to PROLIA® and XGEVA®, both of which are well-established medications in the treatment of osteoporosis and other bone-related conditions.

STOBOCLO® is specifically approved for several indications including the treatment of postmenopausal women with osteoporosis at high risk for fracture, increasing bone mass in men with osteoporosis, and treating glucocorticoid-induced osteoporosis in both men and women. Meanwhile, OSENVELT® is indicated for preventing skeletal-related events in patients with multiple myeloma and those with bone metastases from solid tumors. The introduction of these biosimilars may significantly impact treatment options for patients suffering from these conditions.

According to Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, "We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars. We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and healthcare professionals a valuable alternative treatment option." This launch aligns with Celltrion's commitment to expanding access to high-quality biologic medicines.

The approval of these biosimilars by the U.S. Food and Drug Administration (FDA) follows a comprehensive review process that demonstrated their therapeutic equivalence to the reference products. As a result, these biosimilars are expected to provide more treatment options for healthcare providers and patients alike, particularly in the context of rising healthcare costs.

Historically, the introduction of biosimilars has been a significant factor in reducing drug costs and improving patient access to necessary therapies. Biosimilars are biologic medical products highly similar to already approved reference products, with no clinically meaningful differences in safety or effectiveness. This is particularly relevant in the current healthcare landscape, where affordability and accessibility of medications are increasingly paramount.

The potential social implications of the launch are noteworthy. The availability of cost-effective alternatives may alleviate financial burdens on patients, particularly those with high-deductible health plans or those who are uninsured. In fact, Celltrion offers patient support programs designed to assist individuals in navigating their treatment journeys, including co-pay assistance for those who need it.

In light of this launch, healthcare professionals are encouraged to evaluate the clinical profiles of STOBOCLO® and OSENVELT® in the context of their patients' needs. It is important to consider each patient's specific medical history, particularly in individuals with advanced chronic kidney disease, as the use of denosumab products carries a risk of severe hypocalcemia. Therefore, healthcare providers should monitor calcium levels closely and assess the benefit-risk profile before initiating treatment.

Looking ahead, the launch of these biosimilars could pave the way for further innovations and expansions within the market for biologic therapies. Celltrion's commitment to producing high-quality biosimilars is expected to enhance its portfolio further, responding to the growing demand for affordable therapies in the U.S. The ongoing evolution of the biosimilars market will likely continue to shape treatment paradigms and improve patient outcomes across various therapeutic areas.

In conclusion, the introduction of STOBOCLO® and OSENVELT® represents a significant development in the biopharmaceutical landscape, offering enhanced treatment options for patients with osteoporosis and other bone-related conditions. The potential for improved patient access and decreased treatment costs highlights the critical role biosimilars play in the evolving healthcare environment.