KoreaBIO urges US to exempt Korean pharmaceuticals from potential tariffs

Korea Biotechnology Industry Organization (KoreaBIO), a representative group of some 650 Korean biotech firms, said on Wednesday that it has formally submitted its opinion to the U.S. government regarding the ongoing national security investigation into pharmaceutical and pharmaceutical ingredient imports under Section 232 of the Trade Expansion Act on Tuesday (local time).

The U.S. Department of Commerce launched the investigation on April 1 to assess whether pharmaceutical imports pose a threat to national security. From April 16 to May 7, the Department solicited public comments from stakeholders.

KoreaBIO highlighted two key points in its submission.

First, it said Korea is a reliable partner in the U.S. pharmaceutical supply chain.

“Pharmaceuticals are essential to U.S. patients, and ensuring a stable supply is critical for national security, economic stability, and public health,” the association said.

KoreaBIO referenced a report by the U.S. National Security Commission on Emerging Biotechnology (NSCEB), which advised enhancing innovation and stabilizing supply chains through cooperation with U.S. allies.

“Korea has long played a vital role both in innovative drug development and as a contract manufacturing partner (CDMO) for pharmaceuticals needed in the U.S.,” KoreaBIO said. “Notably, partnerships between Korean firms and U.S. companies in biologics manufacturing have expanded significantly in recent years.”

Korea BIO warned that building a fully domestic pharmaceutical supply chain within the U.S. would take years.

“Imposing tariffs before such infrastructure is ready could jeopardize medicine supplies for American patients, negatively affecting both national security and public health,” the association noted.

Secondly, KoreaBIO said Korea serves as an affordable partner capable of supplying lower-cost prescription drugs to the U.S.

It cited a March survey conducted by its longtime counterpart, the U.S. Biotechnology Innovation Organization (BIO), which found that potential tariffs would increase production costs and reduce access to affordable medicines.

KoreaBIO also noted that President Donald Trump signed an executive order on April 15 aimed at lowering prescription drug prices by increasing the availability of generics and biosimilars.

“As of April 24, 2025, Korean companies have secured the second-highest number of U.S. FDA-approved biosimilars after American firms,” KoreaBIO said, underscoring Korea’s contribution to expanding access to lower-cost medicines and supporting U.S. policy goals. “Pharmaceuticals are vital for national security and patient protection, and countries around the world, including the U.S., rely on each other’s supply chains.”

Korea has played a key role in supplying U.S. patients with essential medicines and pharmaceutical ingredients reliably and affordably, it added.

The association asked the U.S. government to refrain from imposing trade restrictions or tariffs on pharmaceutical products and ingredients.

However, should the administration find it necessary to implement measures following the Section 232 investigation, KoreaBIO requested that products sourced from allied countries like Korea be exempted.

“The association will continue to closely monitor developments regarding potential pharmaceutical tariffs and will work with the Korean government and industry stakeholders to minimize any adverse impact on Korea’s biopharmaceutical sector,” the association concluded.