Celltrion gains European approvals for osteoporosis, bone complication treatments

By Nam Hyun-woo

Celltrion’s two biosimilar treatments for treating osteoporosis and preventing bone metastasis complications in cancer patients have gained approvals for use in Europe, the biotech firm said Tuesday.

The European Commission approved Celltrion’s Stoboclo and Osenvelt biosimilars for treating these conditions. Stoboclo is an alternative to the osteoporosis treatment Prolia, while Osenvelt is a biosimilar to Xgeva, which is used for the prevention of bone complications in cancer patients.

The original drugs are both based on the same active ingredient, Denosumab, and together generated 9 trillion won ($6.23 billion) in global sales last year, cementing their status as blockbuster drugs.

Stoboclo has been approved for treating conditions such as osteoporosis in postmenopausal women and bone loss treatment, while Osenvelt has received approval for the prevention of bone complications in cancer patients, aligning with the indications of their respective original drugs.

Celltrion received approvals for the two biosimilar drugs in Korea in November and has completed the application process for approvals with the U.S. Food and Drug Administration. The company said the European Commission’s approval will help accelerate the drugs' entry into key markets.

With this, Celltrion has now secured approvals for three products from the European Commission this month, including Eydenzelt. Eydenzelt is a biosimilar to Eylea, an eye condition treatment.

So far, Celltrion has gained approvals for 11 products around the world, including its flagship autoimmune disease treatment Remsima and anticancer drug Herzuma. The combined market value of those drugs has reached 150 trillion won, the company said.

“With existing products maintaining solid market shares in Europe, the new products will further enhance Celltrion’s portfolio competitiveness,” a Celltrion official said.

“We will do our best to complete the remaining approval procedures and commercialization, while also accelerating the development of our pipeline to strengthen our market dominance.”