Daijiworld Media Network – Seoul
Seoul, Apr 14: In a major regulatory win, South Korea’s biopharmaceutical giant Celltrion announced on Monday that its biosimilar Yuflyma has received interchangeability approval from the US Food and Drug Administration (FDA), marking a key milestone in its efforts to expand in the world’s largest pharmaceutical market.
Yuflyma, a biosimilar to AbbVie's blockbuster autoimmune drug Humira, can now be substituted at pharmacies in the US without a doctor’s new prescription a privilege reserved for biosimilars that meet stringent efficacy and safety standards.
Citing data from Yonhap news agency, Celltrion said the global Humira market was valued at 12.59 trillion won (approx. $8.99 billion) in 2024, with the US accounting for nearly 80% of sales. With the FDA’s interchangeability status, Celltrion anticipates a significant uptick in Yuflyma's sales, bolstering its position in the lucrative autoimmune drug segment.
“This is a game-changer for us,” the company said in a statement. “The FDA's decision strengthens our competitive edge and aligns with our long-term vision of biosimilar leadership.”
Celltrion currently has 11 approved biosimilars, up from six previously, and has set an ambitious target of 22 biosimilar launches by 2030, by which time the global biosimilar market is projected to nearly double from 138 trillion won in 2025 to 261 trillion won.
In a strong show of internal confidence, Celltrion Chairman Seo Jung-jin announced he will personally invest 50 billion won from May 9 to buy Celltrion shares using his own funds. Additionally, Celltrion Holdings and Celltrion Skincure will invest 100 billion won and 50 billion won, respectively, in share purchases.
"The chairman made the decision to show his commitment to responsible management and enhancing shareholders' value," the company said, adding that the purchases will be conducted during regular trading hours.
Currently, Celltrion Holdings owns 21.96%, while Celltrion Skincure holds 1.89% of Celltrion. The company has also been executing a 350 billion won share buyback and plans to cancel over 800 billion won worth of stock this year a move likely aimed at improving shareholder value and market confidence.
The FDA’s interchangeability approval for Yuflyma not only enhances Celltrion’s access to US pharmacies but also sets a precedent for its expanding biosimilar pipeline amid growing global demand for cost-effective biologics.