Celltrion USA Introduces Denosumab Biosimilars, STOBOCLO® and OSENVELT®, to the U.S. Market
[City, State] – [Date] – Celltrion USA today announced a significant milestone in the U.S. pharmaceutical landscape with the launch of its two denosumab biosimilar products, STOBOCLO® and OSENVELT®. This introduction marks a crucial step forward in expanding patient access to biosimilar alternatives for the widely used biologic medication.
Denosumab is a critical treatment for various bone-related conditions, including osteoporosis in postmenopausal women at high risk of fracture, treatment-induced bone loss, and prevention of skeletal-related events in patients with bone metastases from solid tumors. The availability of biosimilar versions like STOBOCLO® and OSENVELT® is anticipated to offer more affordable treatment options, potentially easing the financial burden for patients and healthcare systems while maintaining the same high standards of safety and efficacy as the reference product.
Celltrion USA, a subsidiary of the global biopharmaceutical leader Celltrion, has a proven track record in developing and bringing high-quality biosimilars to market. The company’s commitment to rigorous scientific research and development has culminated in these two new offerings, which have undergone extensive comparative studies to demonstrate their analytical, clinical, and immunogenicity comparability to the reference denosumab.
The U.S. Food and Drug Administration (FDA) has approved STOBOCLO® and OSENVELT® following a thorough review process, affirming their biosimilarity. This approval is a testament to Celltrion USA’s dedication to meeting the stringent regulatory requirements and contributing to a more competitive and accessible U.S. biosimilar market.
The introduction of STOBOCLO® and OSENVELT® is expected to have a positive impact on the treatment paradigm for bone health in the United States. By providing physicians and patients with additional, high-quality choices, Celltrion USA aims to support improved patient outcomes and contribute to the sustainability of healthcare resources.
This launch signifies Celltrion USA’s ongoing commitment to enhancing patient access to life-changing biologic therapies through the development and commercialization of biosimilars. Further details regarding product availability and specific indications will be made available through healthcare professional channels.
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PR Newswire Healthring published ‘Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo)’ at 2025-07-08 02:08. Please write a detailed article about this news in a polite tone with relevant information. Please reply in English with the article only.