Celltrion is officially entering the global market in the field of osteoporosis treatment. On the 4th (Korean time), Celltrion announced that it had obtained product approval for the osteoporosis treatment biosimilars ‘Stoboclo (STOBOCLO)’ and ‘Osenvelt (OSENVELT)’ from the U.S. Food and Drug Administration (FDA).
Stoboclo and Osenvelt are biosimilars of Prolia and Xgeva, respectively, and Celltrion has demonstrated equivalent efficacy and pharmacokinetic similarity to the original drugs through global phase 3 clinical trials. With this FDA approval, the two products have received sales approval for all indications held by the original drugs in the U.S. market. Stoboclo is used for the treatment of osteoporosis in postmenopausal women, and Osenvelt is used to prevent skeletal complications in cancer patients with bone metastases and to treat giant cell tumors of the bone.
The impact on the global market is significant. Last year, the combined sales of Prolia and Xgeva amounted to approximately $6.59 billion (about 9.2 trillion Korean won), with 67% or approximately $4.39 billion (about 6.15 trillion Korean won) generated from the U.S. market. Having already reached a patent settlement with the original developer, Celltrion is pushing for a U.S. launch as early as this year.
Following the first approval of these items in Korea last November, Celltrion solidified its entry into major markets by obtaining approvals in Europe (EC) in February and the U.S. in March this year. Particularly, it has pre-empted the ‘First Mover’ position ahead of domestic competitors, accelerating the expansion of the osteoporosis treatment market.
Celltrion’s growth isn’t limited to this sector. It has successfully diversified its portfolio by obtaining consecutive approvals in new areas such as autoimmune diseases, oncology, ophthalmology, and bone diseases. This year alone, it acquired three approvals in the U.S. and four in Europe, totaling seven approvals in the two major markets. Last year, Celltrion completed its product portfolio with 11 items in Korea and achieved the same goal in Europe.
A representative from Celltrion stated, “By consecutively acquiring product approvals in major global countries, Celltrion has once again proven its development capabilities. We will make all-out efforts to prepare the subsequent pipeline without delay, swiftly settle it in the market, and drive revenue growth.”
Meanwhile, Celltrion achieved record sales of 3.5 trillion won last year and aims to reach 5 trillion won this year. The company is pursuing a mid- to long-term strategy to achieve annual sales of 12 trillion won by 2030 through 22 products.