Korean drugmakers assess exposure as Trump announces 100% tariff on branded, patented drugs

U.S. President Donald Trump shook global pharmaceutical markets on Friday by warning that all branded and patented drugs manufactured outside the U.S. will face a 100 percent tariff unless companies are building local plants.

In a post on Truth Social at 8:24 a.m. KST on Friday, Trump wrote, “Starting October 1st, 2025, we will be imposing a 100% Tariff on any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America. ‘IS BUILDING’ will be defined as, ‘breaking ground’ and/or ‘under construction.’ There will, therefore, be no Tariff on these Pharmaceutical Products if construction has started. Thank you for your attention to this matter!”

Although Trump’s message referred only to branded and patented medicines, leaving biosimilars and active pharmaceutical ingredients (APIs) seemingly outside the scope, the industry remains cautious until further clarifications are issued.

Currently, four Korean-developed drugs with notable sales in the U.S. could be directly exposed to the tariff risk -- Yuhan’s non-small cell lung cancer therapy Leclaza (marketed as Lecluze in the U.S.), Hanmi Pharm’s neutropenia treatment Rolontis (marketed as Rolvedon), SK biopharmaceuticals' epilepsy drug Xcopri, and Celltrion’s autoimmune therapy Zympentra.

Despite the uncertainties, Korean pharmaceutical companies emphasized that they are well prepared to handle the potential policy shift.

Celltrion said Tuesday it has signed a contract to acquire Eli Lilly’s biopharmaceutical manufacturing plant in Branchburg, New Jersey, for about 460 billion won ($330 million), securing its first U.S. production site.

The company stressed it had prepared short-, mid-, and long-term contingency plans, adding that two years of U.S. inventory have already been secured, while future supplies will come from the local plant.

“We expect no tariff risk once the facility begins supplying,” a Celltrion spokesperson said.

Yuhan also seemed ready for the potential impact of the tariff.

The company noted that rights to Leclaza outside Korea, including manufacturing and distribution, belong to Johnson & Johnson. Yuhan emphasized it is monitoring the situation closely but pointed out that its API exports largely target Europe rather than the U.S.

SK biopharmaceuticals highlighted its preparedness as well.

A company spokesperson stated that the company had already been preparing for uncertainties such as the latest announcement by securing FDA approval for a local facility and initiating U.S.-based production.

Along with the inventory already secured, it judged that there would be little impact from the new policy.

The official further stressed that since the specific details of the policy have not yet been announced, the company will continue to monitor developments.

“Given the relatively small production volume of SK biopharmaceuticals and considering the SK Group’s existing infrastructure in the U.S., the long-term burden of building or operating a plant there would not be significant,” he said.

Separately from company statements, SK pharmteco, an SK biopharmaceuticals affiliate, operates multiple pharmaceutical manufacturing sites in the U.S., including Rancho Cordova in California, and these facilities are known to produce small-molecule APIs.

Other Korean companies exporting branded and patented medicines to the U.S. are also said to be preparing countermeasures in consultation with their partners or are closely monitoring upcoming policy announcements.

According to the KoreaBIO’s report on pharmaceutical trade with the U.S., imports of Korean medicines into the country reached $3.98 billion (about 5.26 trillion won). The U.S. is the world’s largest importer of pharmaceuticals, with Korea ranking as the 16th-largest source of drug imports.