Celltrion said recent changes in U.S. pharmaceutical import policies are unlikely to burden its business with tariffs and may instead create new growth opportunities over the mid to long term.
The U.S. government recently introduced a policy imposing higher tariffs on certain imported pharmaceuticals and raw materials to strengthen domestic supply chains. Under the new framework, patented drugs not produced in the U.S. or not subject to price negotiations could face tariffs of up to 100%. Korean pharmaceutical products are subject to tariffs of around 15% under a country-specific structure. However, companies that establish local manufacturing facilities and enter into most-favored-nation pricing agreements with the U.S. Department of Health and Human Services may qualify for tariff exemptions.
Celltrion noted that biosimilars, which account for a significant portion of its revenue, are excluded from the tariff measures and will be subject to review after one year. As a result, the company expects no immediate impact on its U.S. sales and plans to continue its local sales and marketing activities without disruption.
To prepare for potential policy changes, Celltrion plans to strengthen its manufacturing presence in the United States. The company intends to gradually expand its local production system, centered on its Branchburg, New Jersey facility, with the goal of producing products sold in the U.S. domestically.
Its autoimmune disease treatment Zymfentra is also expected to remain unaffected by tariffs, as active pharmaceutical ingredient (API) production is scheduled at the Branchburg site. Technology transfer for production has already been completed, and Celltrion plans to extend local manufacturing to additional products to structurally mitigate tariff risks.
The policy shift is also expected to increase demand for domestic production among global pharmaceutical companies, which could create opportunities for Celltrion to expand its contract manufacturing (CMO) business. The Branchburg facility is slated for an additional 75,000-liter capacity expansion, which would bring total production capacity to approximately 140,000 liters upon completion. This is expected to enhance both in-house production and global contract manufacturing competitiveness.
A stronger local production base is also likely to improve Celltrion’s direct sales competitiveness. Zymfentra, in particular, has recently seen a sharp increase in prescriptions, and the combination of tariff exemptions and reduced logistics costs is expected to further strengthen its price competitiveness.
Celltrion said that with tariff burdens on its key products effectively removed under the new policy, the company is well-positioned to enhance competitiveness through expanded U.S. manufacturing and capture new business opportunities, accelerating its growth in the U.S. market.
