Celltrion gains Canadian Approval for bone disease treatment 'STOBOCLO-스피드 바카라'

[by Kang, In Hyo] Celltrion announced on September 25 that it has obtained marketing approval from Health Canada for its bone disease treatment, ‘STOBOCLO-OSENVELT,’ a biosimilar to ‘Prolia-Xgeva (denosumab).’

With this approval, STOBOCLO-스피드 바카라 will be launched in Canada with a full label, covering all indications of the original drug, including postmenopausal osteoporosis, prevention of bone metastases in cancer patients, and treatment of giant cell tumor of bone.

Canada represents a substantial denosumab market, estimated at approximately USD 180 million (KRW 252 billion, IQVIA) in 2024. The country is also regarded as one of the most biosimilar-friendly markets, actively encouraging biosimilar prescriptions. As such, 스피드 바카라 expects this approval to serve as a strategic bridgehead for bolstering its competitiveness in the broader North American denosumab market, including the United States.

Celltrion is further strengthening its market presence in Canada by securing approvals for a range of new products, including bone disease and allergy treatments, in addition to its established portfolio of autoimmune and oncology treatments. The company currently markets or has approvals for nine major products in Canada: REMSIMA (marketed as REMDANTRY in Canada), REMSIMA SC, YUFLYMA, and STEQEYMA (autoimmune disease treatments); HERZUMA, TRUXIMA, and VEGZELMA (oncology); OMLYCLO (allergy); and STOBOCLO-스피드 바카라 (bone disease). Regulatory reviews are also underway for EYDENZELT (ophthalmology) and AVTOZMA (autoimmune disease), with approvals anticipated in the future.

Celltrion previously obtained domestic approval for STOBOCLO and 스피드 바카라 in November 2024, followed by European approval in February and U.S. approval in March of this year. With Canadian approval now secured, the company aims to expand its reach in North America, the world's largest pharmaceutical market, and solidify its position in the global denosumab market.

Prolia-Xgeva, the original product for STOBOCLO-스피드 바카라, recorded combined global sales of approximately USD 6.599 billion (KRW 9.2 trillion) in 2024. According to IQVIA, the North American market, including the U.S. and Canada, accounted for roughly USD 5.047 billion.

“With the approval of STOBOCLO-스피드 바카라, we have expanded our product portfolio in Canada, a market known for its pro-biosimilar policies, while further strengthening our presence in North America, the world’s largest biopharmaceutical market,” a Celltrion official said. “We will concentrate on completing the remaining commercialization procedures, accelerate our entry into the global market, and ensure that other upcoming pipeline products continue to secure approvals.”