Celltrion has launched its osteoporosis treatment, 'Stoboclo-Osenvelt' (active ingredient: denosumab), in the United States earlier this month, targeting the global denosumab market valued at approximately 9 trillion won.
This product is a biosimilar to Prolia and Xgeva. In March, Celltrion received approval from the U.S. Food and Drug Administration (FDA) for full-label sales, matching the original in all indications. Furthermore, Celltrion has reached a patent agreement with the original developer to ensure a stable entry into the U.S. market.
Stoboclo-Osenvelt is launched at a 5% reduced high wholesale acquisition cost (High WAC) compared to the original. Similar to its previously launched products like ‘Zymfentra’ (infliximab, marketed in the U.S. as Remsima SC), ‘Yuflyma’ (adalimumab), and ‘Steqeyma’ (ustekinumab), Celltrion's U.S. subsidiary will handle direct sales.
Concurrently with the Stoboclo-Osenvelt launch, Celltrion secured supply contracts with large hospital groups in the U.S., ensuring early market penetration. As product distribution commenced from the launch date, an increase in prescriptions and expanded performance is expected.
Celltrion plans to focus on the "open market" in the U.S., which constitutes about 30% of the denosumab market. This market, primarily supported by direct U.S. government funding to healthcare institutions, has minimal influence from insurers or Pharmacy Benefit Managers (PBMs), making pharmaceutical companies' sales and product competitiveness crucial for market capture. Previously, Celltrion successfully launched the oncology biosimilar ‘Vegzelma’ (bevacizumab) in the open market, achieving a 6% market share by the end of last year.
Besides the open market, Celltrion is in active negotiations with the top three PBMs to successfully penetrate the public and private insurance markets. Considering that most osteoporosis patients are postmenopausal, the company plans to rapidly include the bone disease treatment in formularies targeting the Medicare market, which serves an aging population with high demand. Given Celltrion's ongoing negotiations in the public insurance market, a swift listing of Stoboclo-Osenvelt is anticipated.
Celltrion also plans to accelerate marketing activities aimed at healthcare professionals. Having previously engaged with key medical professionals in rheumatology and oncology during its autoimmune treatment sales efforts, Celltrion intends to leverage these networks to expedite prescription growth in the bone disease treatment market.
With the expansion of its product portfolio, Celltrion’s revenue growth prospects look promising. The original products, Prolia and Xgeva, recorded a combined global revenue of approximately $6.59 billion in 2024, with U.S. sales accounting for about 67% or $4.392 billion.
Thomas Nusbickel, Chief Commercial Officer of Celltrion’s U.S. subsidiary, stated, “The launch of Stoboclo-Osenvelt will provide U.S. healthcare professionals and patients with a broader range of bone disease treatment options, thereby improving medical accessibility. We plan to expand prescriptions in the open market based on Celltrion’s proven sales and distribution network, and effectively advance our negotiations with PBMs to rapidly capture the bone disease treatment market.”
