Celltrion announced on the 18th that it has simultaneously obtained European product approval for the osteoporosis treatment biosimilars Stoboclo and Osenvelt.
Stoboclo and Osenvelt are biosimilars of the original drugs Prolia and Xgeva (ingredient denosumab). Prolia and Xgeva are licensed medications for treating osteoporosis and preventing bone metastasis complications in cancer patients, respectively.
As of 2024, Prolia and Xgeva combined recorded approximately 9 trillion won in sales globally.
Previously, based on the global phase 3 clinical trial results, Celltrion applied for product approval for the two biosimilars, Stoboclo and Osenvelt, in March of last year and obtained approvals for the indications held by the original medications. Stoboclo can be used for treating postmenopausal osteoporosis and bone loss, while Osenvelt can be used for preventing bone metastasis complications in cancer patients and for treating giant cell tumors.
The two products received their first product approval in South Korea in November of last year. The company recently completed the approval application in the United States. As Celltrion has obtained approvals in South Korea and Europe, it plans to accelerate its strategy to target major global markets.
Recently, the company opened the European market for its biosimilar products one after another. Last week, it obtained approval for the ocular disease treatment biosimilar Eydenzelt.
Celltrion explained that if it obtains approval for the autoimmune disease treatment biosimilar Aptozuma, which received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), it will complete its business goal of establishing an '11-product portfolio' that was achieved early in South Korea last year. The combined global market size of 11 major products that Celltrion has sold or received approval for so far amounts to about 150 trillion won.
A company official said, "As existing products maintain a strong market share in Europe and follow-up products receive additional approvals, Celltrion's overwhelming competitiveness can be further enhanced. We will do our utmost in the remaining approval processes and commercialization, and we will accelerate the development of follow-up pipelines to strengthen our market dominance."