Celltrion said on the 6th that the company's tariff impact from the U.S. government's released "adjustment of imports of medicines and pharmaceutical ingredients into the United States" has been effectively resolved.
On the 2nd (local time), the U.S. Donald Trump administration released details related to medicine tariffs through the "adjustment of imports of medicines and pharmaceutical ingredients into the United States." According to this, up to a 100% tariff will be imposed on patented medicines and ingredients that have no production in the United States or have not entered into drug price negotiations with the government.
Under a country-specific differential tariff system, a 15% tariff on medicines will apply to Korea, reflecting existing trade agreements. However, corporations that have signed a most favored nation (MFN) drug price agreement with the Ministry of Health and Welfare (HHS) and have local production facilities may also be exempt from tariffs.
Celltrion emphasized that biosimilars (biosimilar) accounting for most of its U.S. sales were excluded from the scope of this tariff. The items in question will be reassessed in a year.
A company representative said, "With our flagship products excluded from tariffs, we have established a foundation to run our sales and marketing strategy in the United States stably," and added, "We plan to gradually build a local production system in response to future policy changes."
Celltrion is expanding its production capacity centered on its Branchburg plant in the United States. Zymfentra, a subcutaneous infliximab injection sold in the United States as a new drug, is also scheduled to produce drug substance (DS) at the plant, and is expected not to be affected by tariffs.
The company said it has already completed the technology transfer for Zymfentra production and plans to expand local production across its U.S. portfolio going forward. It previously finalized an additional expansion plan of 75,000 liters, and total capacity is projected to increase from 66,000 liters to 141,000 liters.
At the same time, it also expects to expand its global contract manufacturing (CMO) business.
There is also talk of potential earnings improvement from expanded direct sales. Zymfentra's prescriptions this year are said to have more than tripled from a year earlier, hitting a monthly record high. The company believes it can secure price competitiveness given tariff-free treatment and savings in logistics and transportation costs.
A Celltrion representative said, "This policy is positive in terms of strengthening the local production base and expanding new business opportunities," and added, "We will accelerate our growth in the U.S. market through increased prescriptions of key products, including Zymfentra, and growth in our contract manufacturing (CMO) business."