Synopsis
Celltrion, a South Korean biopharmaceutical company, has received interchangeability approval for its biosimilar Yuflyma, intended for autoimmune diseases, from the U.S. FDA. This designation will allow it to be swapped with Humira without a prescription, boosting sales in the lucrative U.S. market.Key Takeaways
- Celltrion has gained FDA approval for its biosimilar Yuflyma.
- The biosimilar is now considered interchangeable with Humira.
- Interchangeable drugs can be substituted at pharmacies without prescriptions.
- Celltrion aims to launch 22 biosimilar products by 2030.
- Share buyback initiatives are underway to enhance shareholder value.
Seoul, April 14 (NationPress) Celltrion, a prominent biopharmaceutical company from South Korea, announced on Monday that it has received interchangeability approval for its biosimilar medication intended for the treatment of autoimmune diseases in the United States.
The U.S. Food and Drug Administration (FDA) has classified Celltrion's biosimilar, Yuflyma, as an interchangeable product with its reference drug, Humira, according to a report by Yonhap news agency.
This approval allows the biosimilar to be substituted for the original medication at pharmacies without the need for a doctor's prescription.
Last year, the overall Humira market was valued at 12.59 trillion won (approximately $8.99 billion), with around 80% of sales occurring in the U.S., as stated by the company.
Celltrion anticipates that this approval will significantly boost sales of Yuflyma in the largest pharmaceutical market worldwide.
The company has notably expanded its global biosimilar portfolio, increasing its approved products from six to 11.
By 2030, Celltrion aims to bring 22 biosimilar products to market, with projections indicating that the global market size will nearly double to 261 trillion won from the current 138 trillion won.
In a prior announcement, Celltrion stated that Chairman Seo Jung-jin plans to purchase 50 billion won worth of Celltrion shares starting May 9, utilizing his personal funds. Additionally, Celltrion Holdings and Celltrion Skincure intend to invest 100 billion won and 50 billion won, respectively, in acquiring shares.
"The chairman's decision reflects his dedication to responsible management and increasing shareholder value," the company commented, noting that the acquisitions will take place during trading hours.
Celltrion Holdings, the parent company of Celltrion Group, holds a 21.96% interest in Celltrion, while Celltrion Skincure possesses a 1.89% stake in the biopharmaceutical firm.
Since the beginning of this year, Celltrion has been engaged in a share buyback program worth 350 billion won, with plans to cancel over 800 billion won in shares by year-end.
