Celltrion Foresees Little Impact from U.S. Drug Pricing Executive Order


Seoul: Celltrion Inc., a leading South Korean biopharmaceutical company, announced that it anticipates minimal impact from U.S. President Donald Trump’s executive order aimed at reducing drug prices by aligning them with those in other countries. The order is designed to address the issue of the United States paying significantly higher prices for prescription medicines compared to other developed nations.



According to Yonhap News Agency, Celltrion Chairman Seo Jung-jin stated in an online press conference that the high drug prices in the U.S. are not primarily due to pharmaceutical companies but are a result of issues within the middle distribution process. Seo explained that Trump’s proposal primarily targets intermediaries, such as pharmacy benefit managers (PBMs) and private-sector insurers, which contribute to increased costs for U.S. patients.



In the current U.S. PBM system, original biologic drugs are typically prioritized in formularies, with biosimilars added through competitive processes. However, rebate issues often result in biosimilars being priced similarly to original drugs when prescribed in hospitals. Seo suggested that if the intermediary distribution structure, including PBMs, is reformed, biosimilar manufacturers like Celltrion could negotiate drug prices directly with the government, bypassing intermediaries and potentially creating more opportunities for the company.



Seo further mentioned that the executive order is unlikely to significantly affect Celltrion’s business, as its biosimilars are already available in the U.S. market at substantially lower prices than original drugs. Additionally, he projected that tariffs on pharmaceutical imports would have little impact on sales. The company’s flagship biosimilars-Remsima, Herzuma, and Truxima-are not subject to import tariffs and are distributed in the U.S. through Pfizer, with sufficient inventories to last up to 21 months.



The Trump administration plans to announce specific tariffs on pharmaceutical imports soon, but Celltrion is preparing for continued growth. Seo revealed that the company is considering establishing a manufacturing facility in the U.S. and has evaluated 48 potential sites in eight states. A decision on the project is expected by the end of the year.



Seo also forecasted that Celltrion’s sales could rise to between 4.6 trillion won (US$3.29 billion) and 4.7 trillion won this year, up from 3.56 trillion won last year. The company has expanded its global biosimilar lineup from six to 11 approved products and aims to commercialize 23 biosimilars by 2030 and 40 by 2038. Additionally, it plans to initiate clinical trials for 13 original drugs by 2035. Currently, Celltrion sells its single original drug, Zymfentra, in the U.S. for treating self-immune diseases.



The global market for Celltrion’s planned 23 biosimilars is projected to nearly double to 261 trillion won by 2030 from 138 trillion won this year. On the stock market, Celltrion fell 0.52 percent to 153,500 won, outperforming the broader Korea Composite Stock Price Index (KOSPI), which declined by 0.73 percent. Despite uncertainties related to Trump’s tariff policies and drug pricing orders, Celltrion shares have decreased by 18 percent so far this year.