As pharma giants line up one after another to tout their investment plans in the U.S., Regeneron is adopting a different tack on the mission to grow its domestic production base and ward off the threat of potential tariffs.
Under a new 10-year agreement, Regeneron will pay CDMO powerhouse Fujifilm Diosynth Biotechnologies more than $3 billion to help manufacture bulk drug product for its commercial biologics in the United States.
The deal, which is slated to nearly double Regeneron’s existing domestic manufacturing capacity, allows the biotechnology giant to secure additional production space at Fujifilm’s sprawling campus in Holly Springs, North Carolina, Regeneron noted in a Tuesday press release.
The technology transfer for the manufacturing accord is “beginning immediately,” Regeneron said, without disclosing the specific drugs Fujifilm will help to produce. The Holly Springs site, which Fujifilm has plugged more than $3.2 billion into so far, is expected to kick off initial operations “later this year,” the CDMO said in a separate press release.
Regeneron and Fujifilm’s manufacturing team-up comes as an onshoring production zeal grips many drugmakers operating in the U.S. The recent trend, which has been marked by major manufacturing investments from the likes of Eli Lilly, Johnson & Johnson, Novartis and Roche, has been inspired in no small part by the threat of sector-specific tariffs on pharmaceutical imports under the second Trump administration.
To hear Regeneron’s CEO Leonard Schleifer, M.D., Ph.D., tell it, his company is “an American success story.”
More than 80% of the drugmaker’s workforce and assets are situated in the U.S., and every medicine for which it has secured FDA approval was invented in its New York laboratories, Schleifer said in a statement.
While the company is going the contracting route on this deal, Regeneron is currently engaged in the expansions and buildouts of several other U.S. facilities, too.
Notably, an ongoing, $3.6 billion expansion of the company’s campus in Tarrytown, New York, is expected to create around 1,000 new jobs and boost Regeneron’s research, manufacturing and support capabilities once complete.
Regeneron is also building a new fill-finish facility in Rensselaer, New York, and has acquired a more than 1-million-square-foot property in Saratoga Springs—also in the Empire State—where the company plans to carry out production support work. The Saratoga Springs site could be used to bolt on additional production capacity in the future, Regeneron added.
Much of the recent push toward U.S. manufacturing is a reaction to the threat of import penalties under President Donald Trump, who has long touted tariffs as a cornerstone of his trade policy. While pharmaceuticals won an exemption in the high-profile round of “reciprocal” tariffs Trump unveiled in early April, duties targeting drugs specifically are still expected to come down the pike “in the next month or two,” Commerce Secretary Howard Lutnick told ABC News earlier this month.
The Trump administration has also been working on what’s known as a Section 232 investigation into pharma imports since the beginning of April. The investigation, which is backed by the Trade Expansion Act of 1962, gives the president the authority to impose trade restrictions, like tariffs, and take other actions if national security threats are uncovered during the probe into pharma product imports.
So far, several large drugmakers have already pledged their support to the U.S. through massive manufacturing and R&D outlays this year, including Roche, whose investment dovetailed with Regeneron’s on Tuesday.
The Swiss drugmaker will invest $50 billion in the U.S. over five years, although some of that sum includes a previously announced consolidation of the company’s cardiovascular, renal and metabolism R&D work at a new center in Harvard’s Enterprise Research Campus.
That said, part of the $50 billion commitment will also be used for the “significant expansion and upgrading” of three existing pharmaceuticals and diagnostics R&D centers” in Arizona, Indiana and California, according to a Roche release.
In its Tuesday press announcement, Roche also teased manufacturing expansions at drug and diagnostics sites in Kentucky, Indiana, New Jersey, Oregon and California, plus an up-and-coming 900,000-square-foot production hub Roche is envisioning to support its pipeline of next-generation weight loss drugs.
Elsewhere, Novartis in early April committed $23 billion to build and expand 10 U.S. facilities over the next five years. Eli Lilly is spending $27 billion to start construction of four new local production plants this year. And Johnson & Johnson has earmarked $55 billion in near-term U.S. spending, which it will channel toward the construction of three new manufacturing sites and the expansion of multiple others already in its medicines and medtech network.