Latest news with #CelltrionInc.
Korea Herald
14-04-2025
- Business
- Korea Herald
Celltrion gets interchangeability approval for biosimilar of Humira in US
Celltrion Inc., a major South Korean biopharmaceutical firm, said Monday it has obtained an interchangeability approval for its biosimilar drug for autoimmune disease treatment in the United States. The US Food and Drug Administration designated Celltrion's biosimilar Yuflyma as interchangeable medicine for its original drug Humira in the US, the company said in a press release. Interchangeability approval is a designation given to drugs that can be substituted for another drug at pharmacies without doctors' prescriptions. The global Humira market reached 12.59 trillion won ($8.99 billion) last year, with nearly 80 percent of the sales in the US market, it said. Celltrion expects the interchangeability approval will help drive up its Yuflyma sales in the world's biggest pharmaceutical market. Celltrion has significantly expanded its global biosimilar lineup, increasing the number of approved products from six to 11. It aims to commercialize 22 biosimilar products by 2030, when the targeted global market size is expected to nearly double to 261 trillion won from 138 trillion won this year. (Yonhap)
Korea Herald
13-03-2025
- Business
- Korea Herald
Celltrion launches autoimmune disease treatment in US
Celltrion Inc., a major South Korean biopharmaceutical firm, said Thursday it has launched its biosimilar product for Stelara, an autoimmune disease treatment, in the United States. Steqeyma, a treatment for plaque psoriasis, Crohn's disease, active psoriatic arthritis and ulcerative colitis, is Celltrion's seventh biosimilar product that has hit the US market, the company said in a press release. The US Food and Drug Administration approved the biosimilar drug in both intravenous and subcutaneous formulations in December, it said. Celltrion has been making efforts to expand its presence in the US biosimilar market. In recent months, it has obtained FDA approval for the US sale of several biosimilars, including Avtozma, an autoimmune disease biosimilar to Actemra, as well as Stoboclo and Osenvelt, biosimilar drugs to Prolia and Xgeva. The global market for Stelara is estimated at US$10.36 billion, with the US accounting for two-thirds of global sales. Celltrion aims to commercialize 22 biosimilar products in global markets by 2030. (Yonhap)
Korea Herald
24-02-2025
- Business
- Korea Herald
Celltrion's autoimmune disease treatment gets approval in Europe
Celltrion Inc., a major South Korean biopharmaceutical firm, said Monday its new biosimilar for an autoimmune disease treatment has obtained approval from the European Commission. The EC approved Celltrion's Avtozma, a biosimilar to Actemra, in both intravenous and subcutaneous formulations, for sales in the member countries of the European Union, the company said in a press release. Avtozma can be used as a treatment for multiple autoimmune diseases, including rheumatoid arthritis and giant cell arteritis. "The EC approval on Avtozma marks a critical step in Celltrion's mission to provide European healthcare systems with affordable, effective solutions for immunological disorders," Ha Tae-hun, senior vice president in charge of Celltrion's European operations, said in the release. Avtozma was also approved by the US Food and Drug Administration for local sales last month. The Korean drugmaker aims to commercialize 22 biosimilar products by 2030, up from the current 11. (Yonhap)
Korea Herald
19-02-2025
- Business
- Korea Herald
Celltrion to buy back W100b of stocks for enhanced shareholder value
Celltrion Inc., a major South Korean biopharmaceutical firm, said Wednesday it will buy back 100 billion won ($69 million) worth of its own stocks to boost its shareholder value. Celltrion will purchase 554,632 stocks during trading hours starting Thursday in its first share buyback of the year, the company said in a press release. The bio firm completed a buyback of about 2.94 million shares valued at 534.6 billion won in 2024. "The company prioritizes improving shareholder value alongside growth, while making efforts to launch new products and further strengthen its presence in the market," a Celltrion official said in the release. Meanwhile, the company said it has canceled 553 billion won worth of stocks, a move approved by its board at the end of last year. (Yonhap)
Korea Herald
31-01-2025
- Business
- Korea Herald
Celltrion gets US FDA approval for new biosimilar for autoimmune disease treatment
Celltrion Inc., a major South Korean biopharmaceutical firm, said Friday its new biosimilar for an autoimmune disease treatment has received approval from the US Food and Drug Administration. The FDA approved Celltrion's Avtozma, a biosimilar to Actemra, in both intravenous and subcutaneous formulations, according to the company. Avtozma can be used as a treatment for multiple autoimmune diseases, including rheumatoid arthritis and giant cell arteritis, as well as COVID-19. "This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers," Thomas Nusbickel, chief commercial officer at Celltrion's branch in the US, said in a press release. Celltrion said Avtozma has great sales potential, noting its original drug, Actemra, raised 2.63 billion Swiss francs ($2.89 billion) globally in 2023. The Korean drugmaker has vowed to commercialize 22 biosimilar products by 2030. (Yonhap)
