Celltrion wins Canadian approval for bone disease biosimilars

(Celltrion)

Celltrion Inc. has received approval from Health Canada for its bone disease biosimilars Stoboclo and Osenvelt, referencing Amgen’s Prolia and Xgeva (denosumab), the company said Thursday.

With the approval, Stoboclo will be prescribed for postmenopausal osteoporosis, while Osenvelt will be available for the prevention of skeletal-related events in cancer patients with bone metastases and for giant cell tumors of bone. Both have been cleared for all original indications of the reference drugs in Canada.

Canada’s denosumab market was valued at about $180 million in 2024, and the country is considered one of the most biosimilar-friendly markets globally.

Celltrion currently markets or has approvals for nine major products in Canada, including autoimmune treatments Remsima (local brand Remdantree), Remsima SC, Yuflyma, and Stekyma; oncology drugs Herzuma, Truxima, and Vegzelma; allergy therapy Omicluo; and now bone disease biosimilars Stoboclo and Osenvelt.

Applications have also been filed for eye treatment Eydenzelt and autoimmune drug Abtozma.

The original drugs Prolia and Xgeva generated combined global sales of around $6.59 billion in 2024, with North America accounting for $5.05 billion, according to IQVIA.

A Celltrion official said the approval will expand the company’s portfolio in Canada and strengthen its presence in North America, the world’s largest biopharmaceutical market.

The company plans to complete commercialization steps and accelerate global expansion while pursuing additional product approvals.