[BIO KOREA 2025] With tariffs looming, Celltrion backs biologics push with US stockpile

Celltrion is drawing a hard line between what built its business and what comes next. At its first-ever booth at BIO KOREA, the Korean biopharma company split its identity down the middle -- literally. 

One wall touted its biosimilar dominance, led by Remsima, which holds over 60 percent of Europe’s infliximab intravenous (IV) market and nearly a third in the U.S. The other projected a pivot: conditionally active multispecific antibodies, dual-payload ADCs, and tumor-selective immunotherapies aimed at hard-to-treat cancers.

It’s a visual metaphor, perhaps, for a company that knows the world is about to change again.

On Thursday, just as BIO KOREA reached its midpoint, Celltrion issued a shareholder update addressing reports that U.S. President Donald Trump is preparing pharmaceutical-specific tariffs as part of a push to reshore drug manufacturing.

In anticipation, Celltrion has already bulked up a U.S. stockpile.

“We have completed the transfer of inventory equivalent to approximately 15 months' supply of our products scheduled for sale in the U.S. in 2025,” the company wrote. The move, it said, was designed to minimize tariff impact through the first half of next year.

But inventory is just step one. Celltrion said it has also secured drug product manufacturing through a U.S.-based contract manufacturing organization, and is actively scouting for a domestic active pharmaceutical ingredient (API) production site, which would be a first for the company.

“We are pursuing a more fundamental, long-term solution by securing local API manufacturing facilities in the U.S.,” the company said.

At the booth, a Celltrion spokesperson told Korea Biomedical Review the company timed its BIO KOREA debut to reflect a turning point. “This is our first time at BIO KOREA,” he said. “And it felt like the right moment. Korea’s bio industry has matured. We saw this as a strategic opportunity, not only to promote Celltrion but to connect with others in the industry.”

The booth’s split design reflected that intent. One display mapped out the company’s global biosimilar footprint: 190,000 liters of manufacturing capacity, approvals in over 100 countries, and Remsima’s leading market share in Europe and the U.S. IV infliximab segment.

Remsima alone is approved in more than 100 countries. Its success in Europe, the spokesperson said, hinged on timing and policy. “Governments recognized the cost savings and began to adopt more favorable policies toward biosimilars. Remsima benefited from that shift and rode the wave.”

But selling biosimilars in Europe isn’t one-size-fits-all, he added. In Germany, drugs are sold through pharmacies at negotiated prices. France uses a national bidding system. The U.K. holds regional tenders, and Norway buys at the national level. “We had to learn how each country worked and adjust our pricing and marketing strategy for each one."

In the U.S., the spokesperson said Pfizer manages sales of Remsima. For newer launches like Vegzelma (bevacizumab), Celltrion has started taking on more of the commercialization effort itself. “Our partner had strong knowledge of the market and was effective in building formulary access and driving share,” he said. “We took those lessons forward, and starting with Vegzelma, we’ve begun playing a more active role in our U.S. commercialization strategy.”

That shift aligns with the company’s U.S. contingency plan. In its statement, Celltrion said it’s ready to expand manufacturing contracts “should additional volumes be needed due to tariff-related changes.” A preliminary review for API production is complete, and a full feasibility study is underway, the company added.

BIO KOREA marked Celltrion’s first booth presence. But the company is already looking ahead to the BIO International Convention, where it plans to accelerate partnering talks tied to its evolving portfolio.

“The BIO International Convention is a key opportunity for us to connect with overseas stakeholders, promote Celltrion, and hold business meetings with people who are interested in our areas of focus,” the spokesperson said. “This year, we also hope to increase communication around the new areas we’re entering—whether that’s novel drug development or CDMO services.”

Roughly 750 people visited the booth on opening day, he estimated. Some were there for the science. Others came for the corporate identity-themed keychains that sold out by mid-morning. Either way, Celltrion had their attention.