Strengthening Business Pipeline with Bio Big 2 for the US Market

Seismic Shifts in U.S. Pharmaceutical Policy: Tariffs and Beyond
Recruitment of Economic Experts and Lobbying Firms to Strengthen Response
North American Sales Surpass 1 Trillion Won Last Year

As the United States, the world's largest pharmaceutical market, is pushing for a rapid shift in trade policy centered on large-scale tariff impositions, South Korea's bio 'Big 2' have strengthened their business and lobbying pipelines targeting the U.S. political and financial sectors.

According to industry sources on the 20th, Samsung Biologics recently appointed former Blue House Policy Chief Lee Ho-seung as an outside director through its regular shareholders' meeting. Lee is a seasoned economic bureaucrat who has held key positions at the Ministry of Strategy and Finance. He entered public service by passing the 32nd Administrative Examination and gained recognition through roles such as Senior Advisor at the International Monetary Fund (IMF), Director of Policy Coordination Bureau, and Director of Economic Policy Bureau at the Ministry of Strategy and Finance. Under the Moon Jae-in administration, he served as the First Vice Minister of Strategy and Finance, then as Senior Secretary for Economic Affairs at the Blue House, and finally as Chief of the Presidential Secretariat's Policy Office.

Samsung Biologics Plant 4 exterior. Photo by Samsung Biologics

Samsung Biologics' recent recruitment is a strategic move to rapidly strengthen its U.S.-related networks within industrial and governmental circles. Lee, having held major positions at the Blue House and Ministry of Strategy and Finance, is expected to help reduce uncertainties about the U.S. market through his networks in U.S. political and institutional spheres. An industry insider said, "An appointment at the level of Blue House Policy Chief corresponds to a U.S. counterpart of ministerial rank or higher," adding, "Especially, Lee's interactions with officials from the first Trump administration and the Biden administration are expected to provide some benefits to Samsung Biologics' business."

The direct connection between Lee and Samsung Biologics also draws attention. During the COVID-19 pandemic in May 2021, Lee led the practical work on the Korea-U.S. vaccine partnership agenda at the Korea-U.S. summit. During the summit, Samsung Biologics signed a contract with Moderna for the contract manufacturing of finished pharmaceutical products (DP). When some claimed this was merely 'simple filling work,' Lee appeared on a radio program and stated, "Bringing in vaccine bulk and producing finished products is by no means a simple technology," adding, "The deeper the relationship between foreign companies possessing key vaccine technologies and our bio pharmaceutical manufacturers, the more cooperation can be enhanced through licensing or direct investment." DP production involves highly complex tasks such as aseptic filling, and only a handful of companies are capable of large-scale production of millions to tens of millions of vials (glass containers for injections).

Celltrion confirmed that it signed a contract last year in the fourth quarter with the local lobbying firm 'Bluebird' through its U.S. subsidiary. This is the first time Celltrion has been known to contract with a U.S. lobbying firm. According to publicly available lobbying information from the U.S. Congress, the firm is expected to handle issues related to U.S. Food and Drug Administration (FDA) regulatory matters and biosimilar-related disputes. Bluebird states on its website that it "provides effective lobbying and consulting in the bio sector" and "strives to engage partners and stakeholders to influence and lead legislative and policy changes." Bluebird's CEO, Kevin Brennan, previously served as chief of staff to U.S. Representative Rosa DeLauro and also worked at the global pharmaceutical company Amgen.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

Lobbying to influence legislation or policy decisions is legal in the United States. The subjects of lobbying, lobbyists, and lobbying amounts are publicly disclosed through congressional websites and other channels.

The Trump administration launched an all-out 'tariff war' immediately upon taking office. It has declared that starting from the 2nd of next month, a 25% tariff will be imposed on pharmaceuticals, which had previously been exempt from tariffs. On the other hand, there is also anticipation that the approval of biosimilar products, in which domestic companies have competitiveness, will become more active and the market will expand further to reduce drug prices. Crisis and opportunity coexist. The North American sales of South Korea's bio Big 2 have each exceeded 1 trillion won. This signifies the growing importance and mutual dependence on the United States, the world's largest pharmaceutical and bio market.