Celltrion launches Stoboclo and Osenvelt in the U.S. to enter ‘denosumab’ 바카라사이트 목록 for bone diseases

[by Kang, In Hyo] Celltrion announced on July 8 that it launched its bone disease treatment, ‘Stoboclo·Osenvelt (denosumab),’ in the United States earlier this month, officially entering the global denosumab 바카라사이트 목록, which is valued at around KRW 9 trillion (approximately USD 6.5 billion).

The newly launched product is a biosimilar (biopharmaceutical generic drug) of Prolia·XGEVA, for which Celltrion received full-label approval, covering all indications, from the U.S. Food and Drug Administration (FDA) in early March of this year, in line with the original drug. In addition, Celltrion finalized a patent agreement with the original drug developer, thereby securing a foundation for stable 바카라사이트 목록 entry in the United States.

Stoboclo·Osenvelt was launched in the U.S. at a high wholesale acquisition cost (High WAC), set approximately 5% below that of the original product. As with previously introduced autoimmune disease treatments, ‘Zymfentra’ (infliximab, 바카라사이트 목록ed as Remsima SC in the U.S.), ‘Yuflyma’ (adalimumab), and ‘Steqeyma’ (ustekinumab), the product will be distributed through direct sales by Celltrion’s U.S. subsidiary.

Coinciding with the launch of Stoboclo and Osenvelt, Celltrion succeeded in securing an early foothold in the U.S. 바카라사이트 목록 by signing a supply agreement with a major hospital group of substantial scale. With product supply to these hospitals beginning immediately upon launch, the company anticipates a rapid increase in actual prescriptions and a swift expansion of 바카라사이트 목록 performance.

Celltrion plans to concentrate its efforts on the U.S. denosumab ‘open 바카라사이트 목록,’ which accounts for about 30% of the total 바카라사이트 목록. The open 바카라사이트 목록 consists of medical institutions directly supported by the U.S. government, and it is characterized by minimal influence from insurance companies or pharmacy benefit managers (PBMs). Hence, the sales capabilities and product competitiveness of pharmaceutical companies are critical to success in 바카라사이트 목록 conquest. Celltrion has already demonstrated strong performance in the open 바카라사이트 목록 by directly launching its anticancer biosimilar ‘Vegzelma’ (bevacizumab), increasing its 바카라사이트 목록 share to 6% by the end of 2024.

Celltrion also aims to successfully establish a strong presence in the public and private insurance 바카라사이트 목록 by smoothly advancing negotiations with the three major PBMs, in addition to its focus on the open 바카라사이트 목록. In particular, recognizing that the majority of osteoporosis patients are in the postmenopausal age group, the company plans to accelerate efforts to secure formulary placement in the ‘Medicare’ system, where demand for bone disease treatments is especially high. Given Celltrion’s ongoing negotiations with major PBMs and ‘public insurance’ programs through its existing product portfolio, Stoboclo and Osenvelt are likewise expected to achieve rapid listing results.

Celltrion also intends to speed up its 바카라사이트 목록ing efforts targeting healthcare professionals. Building on its established communication with key medical experts in related fields such as rheumatology and oncology, developed through the promotion of its autoimmune disease treatments, the company plans to actively utilize this network to drive prescription growth as it enters the bone disease treatment 바카라사이트 목록.

With the expansion of its product portfolio, Celltrion is also expected to see further growth in future sales. As of last year, the combined global sales of Prolia and XGEVA, the original products of Stoboclo and Osenvelt, reached around USD 6.599 billion (approximately KRW 9.2 trillion). Of this total, approximately USD 4.392 billion was recorded in the U.S. 바카라사이트 목록 alone, accounting for 67% of total sales.

“The launch of Stoboclo and Osenvelt will offer U.S. healthcare professionals and patients a broader range of treatment options for bone diseases, thereby enhancing access to healthcare,” said Thomas Nusbickel, Chief Commercial Officer of Celltrion USA. “Leveraging Celltrion’s proven sales force and distribution network built through existing products, we will work to expand prescriptions in the open 바카라사이트 목록 while smoothly advancing negotiations with PBMs to quickly gain a competitive foothold in the bone disease treatment 바카라사이트 목록,” he added.