Celltrion secures FDA approval for bone disease biosimilars

(Celltrion)

Celltrion announced Tuesday that its biosimilars Stoboclo and Osenvelt, referencing bone disease treatments Prolia and Xgeva (denosumab), have received marketing approval from the US Food and Drug Administration.

Stoboclo is approved for treating postmenopausal osteoporosis in women, while Osenvelt is indicated for the prevention of skeletal-related complications in cancer patients with bone metastases and for giant cell tumors of bone. Both products have been approved for all indications covered by the original reference drugs in the US.

Prolia and Xgeva recorded approximately $6.59 billion combined in global sales in 2023, with the US market alone accounting for two-thirds of that at $4.39 billion.

Celltrion plans to launch Stoboclo and Osenvelt in the US market as early as this year, following the completion of a patent settlement agreement with the original drug developer.

In November, Celltrion became the first company in Korea to obtain approval for these biosimilars, ahead of competing products. It also secured approval from the European Commission last month, accelerating its efforts to expand sales in major global markets.

Celltrion has been making aggressive moves to broaden its treatment portfolio, gaining approval for biosimilars for autoimmune diseases, oncology, ophthalmology and bone disease across key global markets. So far this year, the company has obtained three product approvals in the US and four in Europe, totaling seven across both markets.

The company last year already surpassed its goal of establishing an 11-product portfolio in Korea by 2025. It recently met the same goal in Europe.

"Our recent approvals in major global markets reaffirm our in-house biosimilar development capabilities," a Celltrion official said. "We will focus on completing the remaining regulatory approvals for our pipeline products while ensuring the rapid market penetration of approved products to drive revenue growth."