Celltrion announced on the 8th that it has launched the bone disease treatment drug 'Stoboclo-Ocenbelt' (ingredient name denosumab) in the United States this month.
Stoboclo-Ocenbelt is a biosimilar (biopharmaceutical copy drug) of Amgen's Prolia-Xgeva. Stoboclo is for postmenopausal women with osteoporosis, while Ocenbelt received approval from the U.S. Food and Drug Administration (FDA) in March for all disease treatment targets held by the original drug, including prevention of skeletal complications in cancer patients with bone metastases and giant cell tumors. The company has also completed a patent agreement with Amgen, establishing a stable foundation for entering the U.S. market.
This product has been launched at a high wholesale price (High WAC) approximately 5% lower than that of the original product in the United States. Similar to previously launched products like the autoimmune disease treatment drugs 'Jimpenetra' (infliximab; Remsima SC U.S. brand name), 'Uplima' (adalimumab), and 'Steqeyma' (ustekinumab), it will be sold directly by Celltrion's U.S. corporation.
Celltrion successfully secured early market penetration by signing supply contracts with large hospital groups that hold a significant market share in the United States at the same time as the launch of Stoboclo-Ocenbelt. Since product supply to these hospitals is underway as of the launch date, actual prescriptions and performance expansion are expected to follow.
The company plans to focus on the 'open market' that accounts for approximately 30% of the U.S. denosumab market. The open market is a segment where direct support from the U.S. government is provided to medical institutions, and normally has little influence from insurance companies or pharmacy benefit managers (PBMs), making the pharmaceutical company's sales power and product competitiveness effective. Celltrion has already launched its cancer biosimilar 'Vegzelma' (bevacizumab) directly in the open market, recording a 6% market share as of the end of last year.
Not only in the open market, discussions are also underway with the three major PBMs, aiming to accelerate penetration into the public-private insurance market. As most osteoporosis patients are in the postmenopausal age group, there are plans to swiftly promote the inclusion of prescriptions in the Medicare market targeting the elderly.
Marketing activities targeting medical professionals are also expected to expand. Just as the company has communicated with medical professionals in related fields such as rheumatology and oncology while selling autoimmune disease treatment drugs, it plans to utilize this network for its entry into the bone disease treatment market.
The company expects revenue growth from the expansion of its product line. The original product of Stoboclo-Ocenbelt, Prolia-Xgeva, had a combined global sales figure of about $6.599 billion (9.2 trillion won) last year, of which sales in the U.S. accounted for about $4.392 billion (6.15 trillion won), or 67% of the total.
Thomas Nusbickel, Chief Commercial Officer (CCO) of the U.S. corporation, said, "We expect to improve access to healthcare in the U.S. through the launch of Stoboclo-Ocenbelt," adding, "We will not only promote the expansion of prescriptions in the open market but also proceed smoothly with negotiations with PBMs to quickly secure the bone disease treatment market."