Celltrion wins U.S. approval for Stoboclo, Osenvelt biosimilars

Celltrion CI

South Korean biopharmaceutical manufacturer Celltrion Inc. said on Tuesday that its biosimilar versions of the bone disease treatment drugs Prolia (denosumab) and Xgeva (denosumab) received product approval from the U.S. Food and Drug Administration.

Celltrion applied for FDA approval for the biosimilars Stoboclo and Osenvelt after confirming efficacy equivalence and pharmacokinetic similarity to the original drugs via a global Phase 3 clinical trial involving 479 osteoporosis patients worldwide.

With this approval, Stoboclo is now cleared for the treatment of postmenopausal osteoporosis, while Osenvelt has been approved for the prevention of skeletal-related complications in cancer patients with bone metastases, as well as for giant cell tumors of the bone - covering all of the indications held by the original drugs in the United States.

The original versions of Stoboclo and Osenvelt - Prolia and Xgeva - saw a combined global annual revenue for about $6.6 billion in 2024. Of this, the United States alone accounted for 67 percent of global sales, amounting to about $4.4 billion.

Having already reached a patent settlement with the original drug developer, Celltrion plans to launch these two products in the United States, the world’s largest pharmaceutical market, as early as this year.

Celltrion has been expanding its treatment portfolio, securing product approvals in new disease areas such as ophthalmic and bone diseases in addition to its existing autoimmune and oncology drugs, across key global markets.

The company won three U.S. approvals in 2025 to date, including Avtozma, as well as securing four approvals in Europe in February for Eydenzelt, Stoboclo, Osenvelt, and Avtozma.

“The successive approvals of our biosimilars in major global markets reaffirm our in-house product development capabilities,” Celltrion said. “We will ensure that the remaining pipeline approvals are completed without issues while striving for the swift market penetration of approved products to drive revenue growth.”

In its latest earnings report, Celltrion revealed that it surpassed the 2024 revenue target of 3.5 trillion won ($2.4 billion) for a record-high revenue of 3.56 trillion won. The company aims to hit 5 trillion won in annual revenue in 2025 and secure a total of 22 products by 2030 for annual sales of 12 trillion won.