(Celltrion)
(Celltrion)

Celltrion said Monday that tariff-related uncertainties in its US business have largely been resolved following Washington’s revised policy on pharmaceutical imports.

Under the new framework aimed at reshoring drug supply chains, the US will impose a 100 percent tariff on patented drugs and related ingredients not produced domestically or not covered by government pricing agreements. Korea, however, will be subject to a lower 15 percent tariff under a differentiated scheme reflecting existing trade agreements.

Companies that sign a Most Favored Nation pricing agreement with the US Department of Health and Human Services and establish local production facilities may qualify for tariff exemptions.

Against this backdrop, Celltrion said its biosimilar portfolio in the US will be largely shielded from tariff risks, supporting stable sales and marketing operations.

The company plans to strengthen its local manufacturing footprint further to stay ahead of policy shifts. It aims to produce US-bound products at its Branchburg plant in New Jersey.

Its infliximab subcutaneous formulation, Zymfentra, is also expected to remain exempt from tariffs, as its drug substance will be manufactured at the Branchburg facility, Celltrion said.

As the policy requires both finished drugs and active ingredients to be produced in the US, demand for local manufacturing is expected to rise across the industry.

Celltrion expects its Branchburg plant to benefit from the trend. The company plans to expand the facility by an additional 75,000 liters, raising total drug substance capacity from 66,000 liters to 141,000 liters.

A company official said the policy removes tariff risks on key products and is expected to accelerate US growth, driven by expanded Zymfentra prescriptions and its contract manufacturing business.


jwjeon7625@heraldcorp.com