Seoul— South Korean biopharmaceutical giant Celltrion announced Monday that it has received U.S. regulatory approval designating its biosimilar Yuflyma as an interchangeable alternative to Humira, a widely used treatment for autoimmune diseases.
The U.S. Food and Drug Administration (FDA) granted Yuflyma the interchangeability status, allowing pharmacists to substitute it for Humira without a new prescription from a healthcare provider, according to Yonhap news agency.
Celltrion highlighted the significance of the approval, noting that the U.S. accounts for nearly 80 percent of the global Humira market, which reached 12.59 trillion won ($8.99 billion) last year.
The company expects the FDA’s decision to significantly boost sales of Yuflyma in the world’s largest pharmaceutical market.
Celltrion has been aggressively expanding its biosimilar portfolio, growing the number of approved products from six to 11. The firm aims to commercialize 22 biosimilars by 2030, targeting a global market projected to nearly double in size—from 138 trillion won in 2024 to 261 trillion won by the end of the decade.
In a separate development, Celltrion said Chairman Seo Jung-jin plans to purchase 50 billion won worth of company shares beginning May 9, using his personal funds. Celltrion Holdings and Celltrion Skincure also intend to buy 100 billion won and 50 billion won worth of shares, respectively.
“The chairman’s decision reflects his commitment to responsible management and to enhancing shareholder value,” the company said, adding that all purchases will occur during regular trading hours.
Currently, Celltrion Holdings owns a 21.96 percent stake in Celltrion, while Celltrion Skincure holds a 1.89 percent stake.
The company is also conducting a share buyback program worth 350 billion won, with plans to cancel more than 800 billion won in stock by the end of the year. (Source: IANS)
