US-EU Tariffs Bring Uncertainty to Oncology Drug Supply Chains

The US and European Union (EU) announced a comprehensive trade framework on August 21, 2025, establishing a 15% maximum tariff rate for most European pharmaceutical imports to the US, including branded and generic medications.¹ Clinical stakeholders in oncology and other therapeutic areas are advised to monitor evolving regulatory impacts, as this agreement marks a critical inflection point in cross-border drug supply logistics, costs, and future research collaboration.

Key Details of the Trade Agreement

The finalized tariff regime reduces previously proposed rates—which reached as high as 200 to 250%—to a blanket ceiling of 15% on European-produced pharmaceuticals entering the US market, effective September 1, 2025. While certain products, such as aircraft components and select natural resources, will receive favored Most-Favored Nation (MFN) tariff treatment at rates potentially close to 0, branded drugs will generally be subject to the full cap of 15%. “[G]eneric pharmaceuticals and their ingredients and chemical precursors” will be subject to the MFN rate, according to the statement from the White House.

This policy adjustment arrives after a period of uncertainty and heightened concern across the pharmaceutical industry, notably following previous tariff threats from the Trump administration. The deal includes reciprocal concessions, with the EU pledging $600 billion in investments and $750 billion in US energy purchases by 2028.

Implications for Oncology Drug Supply and Costs

For oncology drugs, the impact of a 15% import tariff could be substantial. Industry analysts estimate that the pharmaceutical sector could lose between $13 billion and $19 billion in value because of elevated duties.² Supply chains reliant on European manufacturers of finished medications or component materials, such as vials and stoppers, may encounter particularly acute cost pressures.

Based on US FDA import data from 2023 to 2024, oncologic drugs with ingredients or components imported from the EU include:

• Pembrolizumab (Keytruda)
• Blinatumomab (Blincyto)
• Nivolumab (Opdivo)
• Bevacizumab (Avastin)²

The possible limitations of access to immune checkpoint inhibitors could be significant; as of 2020, an estimated 43.6% of patients with cancer in the US are eligible for the therapy.⁴ Notably, pembrolizumab has 40 approved indications and is the top-selling oncology drug worldwide, with $24.98 billion in sales in the US in 2024.⁵

Generic drugs, which account for 90% of prescriptions in the US,³ will also face the new MFN tariff regime. However, experts suggest that the overall effect on generics may be modified by their already lower manufacturing costs and domestic production levels.²

FAQs

How will the 15% tariff affect import costs of oncology biologics into the US?

The 15% tariff imposed on oncology biologics imported into the US from the European Union is projected to significantly raise import costs. Industry analysts estimate that such tariffs could result in billions of dollars in additional expenses for the pharmaceutical sector, with overall costs ranging from approximately $13 billion to $19 billion annually. The increased tariff will likely be passed down through the supply chain, affecting wholesalers, payers, and ultimately patients.

What impact could tariffs have on ongoing US-EU oncology clinical trials?

Tariffs introduce cost pressures and supply chain risks that may complicate the conduct of US-EU oncology clinical trials, impacting trial costs, site participation, geographic distribution, and potentially innovation timelines.⁶

This article was generated with assistance from Perplexity.ai and NotebookLM. It was edited and reviewed by Targeted Oncology staff. If you have any questions about the use of AI, please contact us.

REFERENCES:

1. Joint Statement on a United States-European Union Framework on an Agreement on Reciprocal, Fair, and Balanced Trade. News release. The White House. August 21, 2025. Accessed August 22, 2025. https://tinyurl.com/3nhvab2c

2. Widely used drugs on US imports list from Europe. News release. Reuters. March 18, 2025. Accessed August 22, 2025. https://tinyurl.com/44b9w85w

3. Office of Generic Drugs. US FDA. Updated May 23, 2025. Accessed August 22, 2025. https://tinyurl.com/5eu5r546

4. Haslam A, Gill J, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for Immune Checkpoint Inhibitor Drugs. JAMA Netw Open. 2020 Mar 9;3(3):e200423. doi: 10.1001/jamanetworkopen.2020.0423

5. Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results. News release. Merck. February 4, 2025. Accessed August 22, 2025. https://tinyurl.com/amcbm67n

6. Peter RM. Trade war: how new U.S. tariffs will impact the biopharma industry. News release. Labiotech. February 19, 2025. Accessed August 22, 2025. https://tinyurl.com/7v2tt8uj