Synopsis
Celltrion, a leading South Korean biopharmaceutical company, has received approval from the FDA for two new biosimilars aimed at treating bone diseases. Stoboclo and Osenvelt are now available in the U.S. market, expanding Celltrion's biosimilar portfolio.Key Takeaways
- Celltrion gains FDA approval for two bone disease biosimilars.
- Stoboclo and Osenvelt are biosimilars to Prolia and Xgeva.
- The global market for these drugs reached 9.2 trillion won last year.
- Celltrion plans to launch 22 biosimilars by 2030.
- Net profit surged to 235.6 billion won in Q4 2023.
Seoul, March 4 (NationPress) Celltrion, a prominent biopharmaceutical company based in South Korea, announced on Tuesday that its two new biosimilars aimed at treating bone diseases have received approval from the United States.
The U.S. Food and Drug Administration (FDA) has granted approval for Celltrion's Stoboclo and Osenvelt, which are biosimilar medications to Prolia and Xgeva, respectively, available in subcutaneous formulations for the U.S. market, as reported in a company press release and by Yonhap news agency.
The combined global revenue for Prolia and Xgeva was estimated to be around 9.2 trillion won (approximately $6.6 billion) last year.
Of this figure, 6.15 trillion won, or 67 percent, originated from sales of these two original drugs in the U.S. last year.
Last month, Celltrion also received FDA approval for the sale of Avtozma, a biosimilar for autoimmune diseases, which is similar to Actemra, available in both intravenous and subcutaneous forms.
The Korean pharmaceutical company aims to launch a total of 22 biosimilar products by 2030, increasing from its current lineup of 11.
In other news, Celltrion reported that its net profit for the fourth quarter surged significantly compared to the previous year, driven by strong sales of biosimilar drugs and a merger with its healthcare subsidiary.
The net income for the quarter ending on December 31 jumped to 235.6 billion won (approximately $164.7 million), a substantial rise from 453 million won during the same timeframe in 2023, as stated in a regulatory filing.
"Our net results were significantly enhanced by increased sales of our biosimilars, including Remsima, Truxima, and Herzuma, in advanced markets, alongside considerable cost savings following the merger with Celltrion Healthcare at the end of 2023," a company representative explained.
Remsima is utilized for treating Crohn's disease and other autoimmune disorders, while Truxima and Herzuma are aimed at cancer treatment.
Operating profit also increased more than tenfold, reaching 196.4 billion won in the fourth quarter, up from 18.4 billion won a year earlier.
Sales nearly tripled to 1.06 trillion won, compared to 382.6 billion won during the same period.
