Celltrion provides shareholders with response strategy for potential Trump tariffs
Celltrion in a notice to shareholders on Thursday said it has come up with a response strategy should the Trump administration implement a tariff policy on pharmaceuticals.
“In a recent speech shortly after his inauguration, U.S. President Donald Trump briefly mentioned that, along with semiconductors and steel, foreign-produced pharmaceuticals would also be subject to tariffs,” Celltrion said.
While Trump has not made specific proposals regarding drug tariffs, Celltrion said it has conducted an analysis of different scenarios and has already put in place a “system capable of responding immediately, regardless of how the policy is implemented.”
The South Korean manufacturer and exporter of biosimilars said the company’s short-term response is to secure sufficient inventory in the U.S.
“We currently have sufficient inventory of our products in the U.S. to meet demand until at least the third quarter of 2025, without the need for additional imports,” according to Celltrion. “For products that are expected to be depleted sooner, we have the capability to produce finished drug pharmaceuticals (DP) from active pharmaceutical ingredients (API) already imported to the U.S.”
Celltrion’s mid-term response to potential Trump tariffs is to shift to a drug substances (DS)-centric supply strategy. The company plans to focus on exporting DS, which it said are subject to lower tariffs rather than finished DP that face higher tariffs and adjust its strategy to produce finished drug products at local manufacturing sites in the U.S.
“We are already exploring cooperation with local companies that have sufficient manufacturing capacity to produce our products,” Celltrion said.
As a potential long-term response, the company said it is evaluating the acquisition or establishment of manufacturing facilities in the U.S. capable of producing both finished drug products and drug substances in an effort to “create a stable supply chain that is less affected by political and social changes in the U.S., while also expanding our market share.”
Last month, Celltrion announced that the FDA approved Steqeyma — its biosimilar to Johnson & Johnson’s Stelara — for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis. Under an agreement with J&J, Steqeyma is expected to be marketed in the U.S. in February 2025.
Celltrion also recently created a wholly-owned CDMO subsidiary, Celltrion BioSolutions, to drive growth beyond its core biosimilar business. Celltrion BioSolutions will provide end-to-end biopharma services, including drug candidate screening, cell line and process development, clinical trial planning, regulatory documentation and commercial production.
The CDMO will break ground on a 100,000-liter production plant in the first half of 2025, with commercial production slated to begin in 2028 and a long-term goal of achieving domestic capacity of up to 200,000 liters.