KOTRA Online Seminar Draws Over 50 Companies
"Korean Firms Must Respond Swiftly to Regulatory Changes"
KOTRA to Provide Support Including Local Partner Matching
The Korea Trade-Investment Promotion Agency (KOTRA) invited pharmaceutical and bioindustry experts active in the United States to discuss response strategies that Korean companies should pursue amid policy uncertainties.
The Ministry of Trade, Industry and Energy and KOTRA held a seminar titled "The Changing U.S. Pharmaceutical Market in 2025: Crisis and Opportunity" on May 21. This online seminar was organized to help domestic companies seeking opportunities amid policy changes such as U.S. President Donald Trump's executive order on drug price reductions and tariff announcements. More than 50 companies from the pharmaceutical and bio sectors participated.
Amid both concerns and expectations regarding fluctuations in the U.S. bio and pharmaceutical market, KOTRA invited industry experts working in the United States to address the direction of bioindustry policy under the new U.S. administration and the resulting opportunities for Korean companies to enter the U.S. market. Aprio Advisory Group, a professional accounting firm specializing in tariffs and customs clearance, stated, "The public comment period for the national security investigation being conducted by the U.S. Department of Commerce ended on May 7," and added, "Since there is a risk of tariff imposition within May, it is necessary to seek preemptive response strategies."
Additionally, Reed Smith, a law firm providing specialized consulting in the pharmaceutical and bio sectors, emphasized, "In addition to tariff policies, Korean companies must respond quickly to regulatory changes due to the U.S. Food and Drug Administration's updated guidelines and the administrative system's shift toward conservatism." An industry expert also commented, "It is important to closely monitor changes within the value chain, distribution, and sales structures of the U.S. biosimilar market." In particular, Pharmasphere Pharmaceutical Group stressed, "Beyond simple monitoring, it is essential to strengthen strategic local cooperation to effectively respond to changes in the regulatory environment."
KOTRA introduced government support programs for domestic pharmaceutical and bio companies, including Tariff Response 119, export vouchers, and export market diversification support projects. In particular, KOTRA plans to continuously promote support for exports to the United States through: ▲ FDA certification consulting using the K-Bio Desk at the New York Trade Center ▲ operation of an integrated Korean pavilion and networking events (KBTP) at BIO USA, the world's largest bio exhibition ▲ and the Global Biopharma Business Partnership (GBPP), a global pharmaceutical export consultation event based on overseas demand from major global pharmaceutical companies.
Kim Myunghee, Vice President and Head of the Innovation Growth Headquarters at KOTRA, stated, "We hope that Korean bio and pharmaceutical companies will be able to find export opportunities in the U.S. market through the rapid dissemination of overseas market information regarding changes in the trade environment and tariff policies." She added, "KOTRA will spare no effort to provide comprehensive support, from overcoming FDA certification challenges, which are the first step for domestic companies' exports, to local partner matching and distribution network establishment."
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