A sweeping executive order signed by U.S. President Donald Trump to slash domestic drug prices has drawn fierce opposition from American pharmaceutical firms, which warn the move could cost the industry up to $1 trillion in revenue over the next decade. But South Korea’s biosimilar makers are eyeing the policy shift as a potential windfall.
The order, signed on May 12, mandates that prescription drug prices in the U.S. be aligned with those in other developed nations. Pharmaceutical companies have 30 days to voluntarily lower prices before the government intervenes directly. Trump cited the disparity in pricing—often three times higher in the U.S. than the OECD average—as justification, promising price reductions of up to 59%. He also vowed to curtail the role of pharmacy benefit managers (PBMs), intermediaries often blamed for inflating drug costs.
While U.S. drugmakers face mounting pressure, the policy is expected to benefit biosimilar manufacturers in South Korea, whose lower-cost alternatives to original biologic drugs stand to gain greater market share.
Biosimilars, which replicate high-priced biologics once patents expire, are generally exempt from the new pricing pressure due to their affordability. Moreover, dismantling the entrenched PBM networks—widely used by large pharmaceutical firms to protect market dominance—could pave the way for Korean companies to expand in the U.S. by negotiating pricing directly with health authorities, improving access and uptake.
“Celltrion’s U.S. business focuses on cost-effective biosimilars, so we are not negatively affected by price cuts,” said Seo Jung-jin, chairman of Celltrion, a leading South Korean biosimilar manufacturer. “If the Trump administration simplifies the current distribution structure, it will create new opportunities for us.”
Washington appears increasingly supportive of biosimilars as a tool to lower healthcare costs. Trump has pushed for faster approval of biosimilars and encouraged doctors to prescribe them more widely. Regulators may also ease clinical trial requirements. The European Medicines Agency has proposed skipping Phase 3 trials if a biosimilar demonstrates sufficient similarity in earlier phases, and the U.S. Food and Drug Administration is expected to follow suit.
At the same time, U.S. courts have begun to curb pharmaceutical giants’ use of patent litigation to block biosimilar competition. In one recent case, Regeneron failed to block Amgen’s biosimilar version of its eye disease drug Eylea, with a court dismissing its patent claims.
Analysts say 2025 could be a turning point. More than 10 blockbuster biologics—defined as drugs with annual sales exceeding 1 trillion won (approximately $730 million)—are expected to lose patent protection in the U.S. this year. The combined U.S. sales of the top 10 of these drugs reached $26.2 billion in 2024.
South Korean drugmakers including Samsung Bioepis, Celltrion and Dong-A ST are accelerating their efforts to enter the U.S. market with biosimilars targeting autoimmune and osteoporosis treatments. Optimism is growing that biosimilars could become the next growth engine for Korea’s pharmaceutical exports, following defense and shipbuilding.
