South Korean drugmaker Dong-A ST has secured US Food and Drug Administration approval for IMULDOSA, its biosimilar version of Johnson & Johnson’s blockbuster drug Stelara. The regulatory green light, received on October 10, marks a crucial step in Dong-A ST’s global expansion plans.
IMULDOSA, co-developed with Japan’s Meiji Seika Pharma, aims to treat inflammatory conditions including plaque psoriasis and Crohn’s disease. It enters a lucrative market, with Stelara generating $10.86 billion in sales.
Intas Pharmaceuticals’ subsidiary, Accord Biopharma, submitted the biologics license application last year following a 2021 global licensing deal with Dong-A ST. The Indian pharmaceutical company plans to market IMULDOSA through its international network, including Accord Healthcare in Europe.
Park Jae-hong, Dong-A ST’s R&D head, cited the approval as validation of the company’s research capabilities and competitiveness. However, the firm faces challenges in penetrating the competitive US biosimilars landscape and differentiating its offering from the original Stelara.
Dong-A ST’s success with IMULDOSA could pave the way for more Korean biotech firms seeking to expand globally, though regulatory hurdles and market acceptance remain significant obstacles.
