[Hinews] SEOUL, South Korea — Celltrion, a leading South Korean biopharmaceutical company, announced on September 25, 2025, that it has received approval from Health Canada for its biosimilar Stoboclo-Osenvelt, a denosumab-based treatment for bone-related conditions. The approval marks a significant step in expanding the company’s footprint in the North American market.

Stoboclo-Osenvelt is a biosimilar referencing Prolia and Xgeva: it is marketed as Stoboclo for postmenopausal osteoporosis, and as Osenvelt for preventing bone metastases and treating giant cell tumors of bone in cancer patients. Health Canada’s approval covers all indications held by the original drugs, broadening the scope for its use in clinical practice.

Canada’s denosumab market, valued at about $180 million USD (252 billion KRW, 2024 IQVIA data), represents a key opportunity for Celltrion given the country’s strong support for biosimilar adoption. The company views Canada as a critical hub for its broader North American expansion strategy.

Celltrion Corporate Identity image. (Photo provided by Celltrion)
Celltrion Corporate Identity image. (Photo provided by Celltrion)

Celltrion already markets eight biosimilar products in Canada, including treatments for autoimmune diseases, cancer, and allergies. The addition of Stoboclo-Osenvelt strengthens its portfolio in bone disease therapies. The company is also awaiting Canadian approval for two other biosimilars: Eydenzent, for eye disorders, and Aptezma, for autoimmune conditions.

The approval follows previous authorizations in South Korea (November 2024), Europe (February 2025), and the United States (March 2025), completing Celltrion’s entry into major global markets for this product. The original drugs, Prolia and Xgeva, generate global annual sales of approximately $6.6 billion USD (9.2 trillion KRW), with North America accounting for about $5 billion USD (7 trillion KRW).

A Celltrion spokesperson said, “This approval accelerates our expansion in the North American market. We are committed to completing commercialization preparations seamlessly and securing approvals for our pipeline products in a timely manner.”

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