Daijiworld Media Network- Seoul
Seoul, Mar 4: South Korean biopharmaceutical giant Celltrion announced on Tuesday that its two new biosimilars for bone disease treatment have received approval from the United States Food and Drug Administration (FDA).
In a statement, the company confirmed that the FDA has approved Stoboclo and Osenvelt, biosimilar versions of Prolia and Xgeva, respectively, for subcutaneous administration in the US market. The development marks a significant expansion of Celltrion's presence in the global biopharmaceutical sector.
The worldwide market for Prolia and Xgeva was estimated at 9.2 trillion won ($6.6 billion) last year, with the United States accounting for 67 percent, or 6.15 trillion won, of the total sales.
The FDA approval for these biosimilars follows Celltrion’s recent success in securing US authorization for Avtozma, an autoimmune disease biosimilar to Actemra, available in both intravenous and subcutaneous formulations.
Celltrion has set ambitious goals, aiming to commercialize 22 biosimilar products by 2030, up from its current portfolio of 11.
Celltrion’s financial performance saw a dramatic upturn in the fourth quarter of 2023, driven by robust sales of its biosimilars and the successful merger with its healthcare affiliate.
The company reported a net profit of 235.6 billion won ($164.7 million) for the three months ending December 31, a significant surge from just 453 million won in the same period of 2023.
A company spokesperson attributed the impressive growth to increased sales of biosimilars such as Remsima, Truxima, and Herzuma in advanced markets, coupled with substantial cost reductions following the merger with Celltrion Healthcare in late 2023.
• Remsima is a treatment for Crohn's disease and autoimmune conditions.
• Truxima and Herzuma are used in anti-cancer therapy.
Additionally, operating profit soared over tenfold to 196.4 billion won, compared to 18.4 billion won a year ago. The company's sales nearly tripled, reaching 1.06 trillion won, up from 382.6 billion won during the same period.
With its latest FDA approvals and strong financial growth, Celltrion is poised to further strengthen its footprint in the global biosimilar market.