Celltrion Inc., South Korea’s biosimilar-developing leader, is closing in on its first US acquisition, which is expected to enable the company to locally produce nearly all of its flagship biosimilars for the world’s largest pharmaceutical market amid mounting tariff concerns.
The company announced Tuesday that it has been selected as the preferred bidder for a biologic manufacturing plant in the US owned by a major global pharmaceutical company after beating two larger multinational companies.
It plans to spend about 700 billion won ($503 million) to buy the plant, Celltrion Chairman Seo Jung-jin said during a news conference on the same day.
Under a confidentiality agreement, the seller's name will remain undisclosed until both parties sign a binding contract, expected in early October.
The acquisition, subject to final due diligence, would give Celltrion a US-based facility certified under current good manufacturing practice (cGMP) regulations. The plant has been used to produce drug substances for oncology and autoimmune treatments.
Celltrion's headquarters in Korea The deal marks a strategic milestone for the Korean biosimilar giant, allowing it to manufacture its high-demand biosimilars locally and mitigate exposure to potential hefty US tariffs on imported pharmaceuticals, which the Donald Trump administration had previously threatened to raise to as much as 200%.
To avoid high duties, Celltrion has stockpiled up to two years’ worth of inventory in the US and agreed to locally produce its products in the country with domestic contract manufacturing organizations.
CAPACITY RAMP-UP
Under the terms of the deal, Celltrion will exclusively produce the current plant owner’s biologics for the next five years, utilizing half the plant’s capacity.
The remaining output will support Celltrion’s own portfolio of follow-on biologics marketed in the US.
Depending on sales of its biosimilars in the US and new product pipelines, the company would ramp up the plant’s capacity to as much as 1.5 times that of its second Korean plant in Songdo, Incheon.
Steqeyma (Courtesy of Celltrion) Chairman Seo said the company plans to invest up to 700 billion won additionally in expanding the facility’s capacity.
Once the ramp-up is completed, the US plant is expected to support the entire production cycle for Celltrion’s US product lineup.
The company already operates a Boston-based R&D center and maintains a nationwide distribution network through its US marketing unit.
Celltrion currently has 11 biosimilar products approved by the US Food and Drug Administration (FDA), including Inflectra, Truxima, Herzuma, Vegzelma, Yuflyma, Avtozma, Steqeyma, Stoboclo and Osenvelt. Its novel biologic Zymfentra is also available in the US.
