Celltrion announced on the 4th that its biosimilar 'Stoboclo-Osenvelt' for the treatment of bone diseases, the biosimilar of the medication 'Prolia-Xgeva,' has obtained approval from the U.S. Food and Drug Administration (FDA).
Stoboclo (STOBOCLO) has been approved for the treatment of postmenopausal osteoporosis, while Osenvelt (OSENVELT) has been approved for preventing skeletal complications in patients with bone metastatic cancer and for treating giant cell tumors of bone. Each has been approved for all indications held by the original medication in the United States.
The original drug for this medication, Prolia-Xgeva (ingredient name denosumab), had a total global revenue of approximately $6.599 billion (about 9.2 trillion won) last year. The annual revenue in the United States is about $4.392 billion (approximately 6.15 trillion won), accounting for 67% of global sales.
Celltrion plans to launch the two products in the United States as early as this year, having completed patent agreements in advance with the original drug developers.
Previously, Celltrion obtained approval for the relevant competing products in Korea in November last year and secured approval in Europe (EC) last month, completing a lineup of 11 products.
A Celltrion official noted, "We are reaffirming our product development capabilities by consecutively obtaining approvals for biosimilars in major countries globally. We will ensure the smooth completion of the approval procedures for the remaining follow-up pipeline (products under development) and work hard to expedite the market penetration of approved products, leading to increased sales."