The Biosimilars Forum Submits Comments Highlighting Biosimilars as Safe and Effective Lower-Cost Medicines for Americans that Need Them

The Forum’s Comments Address the Section 232 Investigation

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement following the submission of the Biosimilars Forum’s comments to the Department of Commerce regarding their ongoing Section 232 investigation into the national security impact of imports of pharmaceuticals and pharmaceutical ingredients.

“The Biosimilars Forum submitted comments to the Department of Commerce and Secretary Lutnick that highlight the importance of safe and effective biosimilars to lower prescription drug costs for Americans. Biosimilars are integral to the overall integrity of the American pharmaceutical supply chain and should be free from any tariffs so these medicines can continue to provide significant cost-savings to Americans battling disease. Biosimilars are a commonsense solution to skyrocketing drug costs for Americans, but tariffs on the biosimilar industry could end the promise of lower-cost prescription drugs forever.

“Imports of biosimilar medicines (and their inputs) do not threaten or impair the national security of the United States. In fact, biosimilars provide diversification, resilience, and security to domestic supply chains. Biosimilars increase options for American patients—ensuring that the U.S. cannot lose sole access to medicines Americans need to treat conditions like cancer, arthritis, psoriasis, diabetes, and more. It’s also important to understand the American biosimilar industry’s domestic production cannot meet U.S. patient demand.

“Import restrictions on biosimilars would undermine key Administration objectives. President Trump’s April 15, 2025, Executive Order on Lowering Drug Prices, specifically calls out the objective of lowering drug prices in the United States, including through increased utilization of biosimilars. Tariffs on biosimilar products should be avoided because they would be both unnecessary and at odds with the President’s objectives of lowering drug prices for Americans.

Biosimilars are lower-cost medicines that require complex development, sophisticated manufacturing facilities, and highly skilled employees. These complex, low-margin medicines face ongoing domestic market barriers, including those put in place by pharmacy benefit managers. As such, the likelihood of biosimilars being targeted for foreign disruptions is low. There is no incentive for foreign nations to “weaponize” control over biosimilars, as

such actions would have very limited impact. Adding a tariff to a low margin product like a biosimilar will have a negative impact on American patients, U.S. healthcare costs, and the U.S. biosimilar industry. To grow the biosimilars industry and achieve billions of dollars in cost savings, the focus, as President Trump has emphasized, needs to be on building the U.S. biosimilars marketplace and removing barriers to patient access.

“Since the first approved biosimilar by the FDA in 2015, more than 70 biosimilars have been approved for use by Americans, saving the U.S. healthcare system $56 billion with the potential to save an additional $181 billion in the next five years. While the industry intends to keep producing lower-cost biosimilars across dozens of therapeutic areas, new tariffs, combined with already-existing low margins and access barriers, compound issues for our industry and threaten the viability of many U.S. biosimilar manufacturers.

“America faces a time-sensitive ‘biosimilars void.’ Of the 118 biologics set to lose patent protection in the next decade, only 10% have biosimilar in development. With U.S. biosimilar companies investing $100 million to $300 million to develop a biosimilar, along with committing six to nine years to earn eventual FDA approval, tariffs will multiply existing low margins and sales. Rather, our industry needs solutions to domestic market barriers that already jeopardize our industry’s ability to continue research and production.

“The Forum is ready to work with the Trump Administration and policymakers to eliminate existing barriers that prevent patients from having access to lower-cost medicines. We believe the partnership between our members and the Administration has a high potential to deliver efficiency in government, cost savings, and care for Americans in need.”

For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.

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MEDIA CONTACT:

Scott Lusk

Signal Group, EVP

202-288-3233; slusk@signaldc.com