Celltrion said on the 25th that it has obtained product approval from Health Canada for the bone disease treatments "STOBOCLO" and "OSENVELT."
STOBOCLO and OSENVELT are biosimilars (biopharmaceutical copies) of "Prolia/Xgeva" (ingredient denosumab). Celltrion first received approval in Korea in Nov. last year, followed by approvals in Europe in Feb. and the United States in Mar. this year, and it has now secured a path to launch the products in Canada as well.
STOBOCLO can be prescribed for postmenopausal osteoporosis, and OSENVELT can be prescribed for the prevention of complications from bone metastasis in cancer patients and for giant cell tumor of bone, covering all the same indications as the original drugs (full label). Last year, the global sales of the original drugs Prolia and Xgeva, owned by Amgen in the United States, were about $6.599 billion (about 9.2 trillion won), with North American market sales reaching $5 billion (about 7 trillion won).
Canada is a representative country that actively encourages the use of biosimilars, so Celltrion expected that this approval, along with the United States, would serve as a bridgehead for targeting the North American market. As of last year, the denosumab market in Canada was about $180 million (approximately 252 billion won) in size.
A Celltrion official said, "By expanding our new product lineup in Canada, we have further strengthened our presence in North America, the world's largest biopharmaceutical market," and added, "We will focus on preparing the remaining commercialization procedures to accelerate market entry and do our best to ensure that approvals for other follow-up products continue."
The products Celltrion has received approval for in Canada are nine in total: ▲ Remsima, Remsima SC, Yuflyma, Steqeyma (autoimmune disease treatments) ▲ Herzuma, Truxima, Vegzelma (anticancer drugs) ▲ Omlyclo(allergy treatment) ▲ STOBOCLO, OSENVELT (bone disease treatments). The company said that the ophthalmic disease treatment "Idenzelt" and the autoimmune disease treatment "Aptozma" are also under review for approval.