Celltrion Secures Canadian Approval for Bone Disease Treatments Stoboclo-Osenvelt

Strengthening Competitiveness in the North American Market Through Product Portfolio Expansion

Celltrion announced on September 25 that it has received product approval from Health Canada for its biosimilar 'Stoboclo (STOBOCLO)-Osenvelt (OSENVELT)' of the bone disease treatment 'Prolia-Xgeva' (active ingredient: denosumab).

With this approval, Stoboclo is expected to be prescribed for postmenopausal osteoporosis, while Osenvelt will be prescribed for the prevention of bone metastasis complications in cancer patients and giant cell tumors of bone. Each biosimilar will be available for all indications (Full Label) held by the original drugs in Canada.

Canada, with a denosumab market worth approximately 180 million dollars (about 252 billion KRW) as of last year, is considered one of the most biosimilar-friendly countries, actively encouraging biosimilar prescriptions. As such, this approval is expected to serve as an effective bridgehead for strengthening Celltrion's presence in the North American denosumab market, including the United States.

Celltrion is solidifying its position in the market by successively obtaining product approvals for new portfolios such as bone disease and allergy treatments, in addition to its already marketed autoimmune disease treatments and anticancer drugs in Canada.

To date, Celltrion's major products that are either being sold or have been approved in Canada include: ▲Remsima (marketed in Canada as Remdantree), Remsima SC, Yuflyma, and Stekima (autoimmune disease treatments); ▲Herzuma, Truxima, and Begzelma (anticancer drugs); ▲Omriclo (allergy treatment); and ▲Stoboclo-Osenvelt (bone disease treatment), totaling nine products. The eye disease treatment Idengelt and the autoimmune disease treatment Aptozma have completed the approval application process, and the company expects to receive product approvals for these in the near future.

Celltrion began by obtaining domestic approval for Stoboclo and Osenvelt in November last year, followed by additional approvals in Europe and the United States in February and March of this year, respectively. With the completion of product approval in Canada this month, the company now plans to target the North American market, the world's largest pharmaceutical market, and smoothly establish its presence in the global denosumab market.

The original products, Prolia and Xgeva, recorded combined global sales of approximately 6.599 billion dollars (about 9.2 trillion KRW) as of 2024. According to global market research firm IQVIA, the total North American market, including the United States and Canada, was about 5.047 billion dollars (about 7.0658 trillion KRW).

A Celltrion representative stated, "With the approval of Stoboclo-Osenvelt, we have expanded our new product portfolio in Canada, which pursues biosimilar-friendly policies, thereby further strengthening our influence in North America, the world's largest biopharmaceutical market. We will focus on preparing for the remaining commercialization procedures to accelerate our entry into the global market and do our utmost to ensure that approvals for other follow-up products continue to be granted."

This content was produced with the assistance of AI translation services.