After a year in the shadows, the controversial BIOSECURE Act could make a return following an endorsement of a revised iteration by both chambers of Congress.
The bipartisan amendment, submitted by Bill Hagert and Gary Peters, Republican and Democratic senators respectively, was passed through the Senate and House versions of the National Defense Authorization Act of 2026 (NDAA).
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“The next step is for the House of Representatives and Senate to reconcile their versions of the NDAA. We do expect to see BIOSECURE 2.0 (as we are calling it) in the final,” said law firm Goodwin in response to the news.
At its core, the legislative framework has the same aim as previous iterations. The BIOSECURE Act, a section formally “Prohibition on Contracting with certain Biotechnology providers”, is designed to limit Chinese biotechs and manufacturers from accessing US funding and collaborating with US pharma companies using federal funding.
However, the latest amendment, submitted at the end of July 2025, does not name specific Chinese companies. Notably, China-based contract manufacturer WuXi AppTec and previously a key target of the Act has been omitted, which is a significant development given the company’s prominent role in the global pharma industry. The contract research, development, and manufacturing organisation (CRDMO) had been one of five Chinese life science companies named in a previous version of BIOSECURE.
“Generally, [certain Senators] opposed the previous iteration’s explicit naming of certain entities and, in their view, its insufficient protections for due process,” said law firm Arnold & Porter in August 2025.
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By GlobalDataThe latest framework instead opts for more broad stroke association. An entity implicated in the Act is one included in the Federal Register by the Department of Defense of Chinese military companies operating in the US.
Any biotech specialist who is determined to be under the influence of a foreign adversary’s government and subsequently poses a risk to US national security is also a “company of concern.”
“There are no companies explicitly identified in the new legislation; however, WuXi AppTec and others could potentially be designated as a biotechnology company of concern,” Goodwin commented.
The current wording asks that the director of the Office of Management and Budget publish a list of the entities that constitute biotech companies of concern “not later than one year after the date of the enactment of this Act.”
GlobalData Life Sciences research analyst Cyrus Fan commented: “The amendments to the Senate’s Biosecure Act give some relief for the biopharma industry. In the original bill, the inclusion of the WuXi companies had caused concern within the biopharma industry, as the companies are key to a significant number of US-based manufacturer supply chains.”
Fan noted, however, that there “is still uncertainty about whether the Biosecure Act will become law, given the fact that the act was left out of the defense legislation in 2024.”
BIOSECURE did not make it through the $886bn National Defense Authorisation Act for Fiscal Year 2025, a knockback that firmly placed it in legislative limbo. However, Trump, who championed the initiative upon its unveiling in December 2023, has deprioritised the Act in favour of manufacturing onshoring and drug pricing reforms during his second term.
However, the Senate’s endorsement of the latest iteration means the BIOSECURE Act is at least back on Trump’s agenda.
Controversy has continually surrounded the BIOSECURE Act, despite it going through several amendments. Concerns have been raised about the impact the bill would have on the R&D and manufacturing of medicines, given the heavy reliance on Chinese companies in the supply chain. For example, WuXi has one of the largest biologics manufacturing networks globally and is a frequent partner among big pharma companies.
WuXi and BGI have maintained their opposition to the bill. Wuxi has previously called it “a pre-emptive and unjustified designation”, while BGI said the bill contains “falsehoods and baseless allegations.”
Analysis from GlobalData in 2024 stated that the pharma industry could be significantly destabilised due to BIOSECURE legislation.
Editor’s note: This article was updated shortly after publication to include GlobalData analyst comments.
