Celltrion announced a significant reduction in tariff-related uncertainties for its U.S. business, following Washington’s recently revised policy on pharmaceutical imports. This strategic development positions the company for more stable operations in the critical U.S. market.
Under the new U.S. framework, specifically designed to bolster domestic drug supply chains, a substantial 100 percent tariff will be imposed on patented drugs and associated ingredients not produced domestically or covered by government pricing agreements. However, reflecting existing trade agreements, Korea benefits from a differentiated scheme, subject to a significantly lower 15 percent tariff.
Furthermore, pharmaceutical companies can achieve full tariff exemptions by signing a Most Favored Nation (MFN) pricing agreement with the U.S. Department of Health and Human Services and establishing robust local production facilities within the United States.
Against this favorable backdrop, Celltrion anticipates its comprehensive biosimilar portfolio in the U.S. will be largely shielded from major tariff risks. This protection is expected to facilitate stable sales performance and uninterrupted marketing efforts across its product lines.
Proactively addressing future policy shifts, Celltrion is committed to strengthening its local manufacturing footprint. The company plans to leverage its state-of-the-art Branchburg plant in New Jersey for the production of its U.S.-bound pharmaceutical products.
Celltrion specifically highlighted that its innovative infliximab subcutaneous formulation, Zymfentra, is expected to remain exempt from these tariffs. This critical exemption is secured because its key drug substance will be manufactured directly at the Branchburg facility.
As the updated policy mandates that both finished drugs and active pharmaceutical ingredients (APIs) must be produced within the U.S., a substantial increase in demand for local manufacturing capabilities is projected across the entire pharmaceutical industry.
Celltrion’s Branchburg plant is strategically positioned to capitalize on this growing trend. The company plans a significant expansion of the facility, adding an impressive 75,000 liters, which will boost its total drug substance capacity from 66,000 liters to a robust 141,000 liters.
A company official affirmed that this new policy effectively removes significant tariff risks on Celltrion’s key products, thereby accelerating U.S. market growth. This anticipated expansion will be driven by the projected rise in Zymfentra prescriptions and the strategic growth of its contract manufacturing business.
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