Trump Administration Signals Pharmaceutical Tariffs as Alzheimer's Drug Gains EU Approval

In a week of significant developments for the pharmaceutical industry, the Trump administration has hinted at upcoming tariffs on drug imports, while Eisai and Biogen's Alzheimer's treatment Leqembi secured European approval. These events, coupled with manufacturing expansions and biosimilar developments, underscore the dynamic nature of the global pharmaceutical landscape.

Potential U.S. Tariffs on Pharmaceutical Imports

The Trump administration has launched a Section 232 investigation into the national security implications of pharmaceutical imports, paving the way for potential tariffs. Commerce Secretary Howard Lutnick stated that drug tariffs could be announced "in the next month or two." This move has raised concerns within the industry, particularly among generic manufacturers who operate on slim margins. The Indian Pharmaceutical Alliance has warned that such tariffs could significantly impact generic drug producers, potentially affecting drug prices and availability in the U.S. market.

Leqembi Receives European Commission Approval

Eisai and Biogen have achieved a significant milestone with the European Commission's approval of Leqembi (lecanemab) for early-stage Alzheimer's disease. The authorization covers patients with mild cognitive impairment, with specific genetic and biomarker criteria. In Europe, the drug's use is restricted to individuals with one or no copies of the ApoE4 gene and confirmed presence of amyloid beta plaques in the brain. This approval marks a crucial step in expanding treatment options for Alzheimer's patients in the European Union.

Manufacturing and Biosimilar Developments

Kyowa Kirin has completed construction of a new ¥16.8 billion ($118 million) biologics manufacturing facility in Takasaki, Japan. The plant will focus on producing investigational biologics for early-stage development and serve as a training center to address Japan's shortage of experienced biopharma production engineers.

In the biosimilar arena, Biocon Biologics has reached an agreement with Regeneron regarding its Eylea (aflibercept) biosimilar, Yesafili. The interchangeable biosimilar, approved by the FDA last year, is set for U.S. launch in the second half of 2026, or potentially earlier under certain conditions. This settlement has led to the dismissal of pending litigations between the two companies.

Strategic Partnerships and Acquisitions

Daiichi Sankyo has entered a collaboration with Wayfinder Biosciences to develop RNA-targeting small molecules for neurodegenerative diseases. While financial details were not disclosed, this partnership leverages Wayfinder's platform for quantitative insights into small molecule-RNA interactions.

In a move to strengthen its presence in the Chinese market, Haleon has acquired the remaining 12% stake in Tianjin TSKF Pharmaceutical for approximately 1.62 billion Chinese yuan ($220 million). This joint venture, established in the 1980s, has become a household name in China with popular over-the-counter brands such as the Fenbid line of ibuprofen products. The company reported revenue of 3.56 billion yuan ($490 million) in 2024.