Celltrion has announced that its biosimilars, Stoboclo and Osenvelt, have received marketing approval from the U.S. Food and Drug Administration (FDA). These biosimilars, which reference the bone disease treatments Prolia and Xgeva (denosumab), are approved for various indications in the United States.
Stoboclo has been cleared for the treatment of postmenopausal osteoporosis in women, while Osenvelt is approved for preventing skeletal-related complications in cancer patients with bone metastases and for treating giant cell tumors of bone. Both products are approved for all indications covered by their reference drugs in the U.S. market.
In 2023, Prolia and Xgeva generated a combined global revenue of approximately $6.59 billion, with the U.S. accounting for about $4.39 billion of that total.
Celltrion plans to launch Stoboclo and Osenvelt in the U.S. later this year, following a patent settlement agreement with the original drug developer.
In November 2024, Celltrion became the first Korean company to secure approval for these biosimilars, ahead of its competitors. The company also received approval from the European Commission last month, bolstering its efforts to expand its market presence in key global regions.
The approval marks a significant step in Celltrion’s aggressive strategy to diversify its treatment portfolio. The company has previously gained approval for biosimilars in areas such as autoimmune diseases, oncology, ophthalmology, and now bone disease, across major global markets. So far in 2025, Celltrion has obtained three product approvals in the U.S. and four in Europe, bringing the total to seven across both regions.
Celltrion also surpassed its goal of building an 11-product portfolio in Korea by 2025 and recently achieved the same target in Europe.
A Celltrion representative commented, “Our recent approvals in key global markets are a testament to our strong in-house biosimilar development capabilities. We will continue to focus on securing remaining regulatory approvals for our pipeline products while ensuring rapid market penetration of approved products to drive revenue growth.”
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