Stoboclo-Osenvelt is a biosimilar to the reference drugs Prolia and Xgeva, designed to treat postmenopausal osteoporosis (marketed as Stoboclo) and to prevent bone metastases and treat giant cell tumors of bone in cancer patients (marketed as Osenvelt). 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 approximately $180 million USD (252 billion KRW, based on 2024 IQVIA data), is a key target for Celltrion due to the country’s strong support for biosimilar adoption. The company views Canada as a critical hub for its broader North American expansion strategy.
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.
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.”
Kim Kuk Ju, HEALTH IN NEWS TEAM
press@hinews.co.kr
