Biosecure Act
BIOSECURE Act set for Congress vote after inclusion in annual defence bill
After years in legislative limbo, the BIOSECURE Act – albeit with a softer framework – is poised to enter the home stretch on Capitol Hill before being enacted into US law. Congress released the final draft compromise version of the FY26 National Defense Authorization Act (NDAA), wherein the BIOSECURE Act has been confirmed as part of the package. The annual bill authorises a record $901bn in national security spending next year, billions more than US President Donald Trump's request.
The bipartisan BIOSECURE amendment, submitted by Republican Senator Bill Hagert and Democratic Senator Gary Peters, was passed through the Senate and House versions of the NDAA. The inclusion in the final draft reflects weeks of additional negotiation between the two chambers of Congress.
The House is expected to vote on the NDAA this week, with the Senate to follow before the end of December. If passed by both bodies, it will then be handed to Trump for approval. Congress has greenlit the annual defence bill every year for decades and is considered “must-pass” legislation.
At its core, the legislative framework for biotech security has the same aim as previous iterations. The BIOSECURE Act, a section formally called “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. Instead, equipment or service restrictions will apply to identified “biotechnology companies of concern”, including those on the US Department of Defense’s (DoD) 1260H list and companies designated through a national security process by the Office of Management and Budget (OBM). This proposed framework opts for a broader stroke association, rather than targeting specific companies.
China-based companies are responsible for 20% of drugs in development globally, reflecting the powerhouse role the country has in the pharmaceutical industry. Licensing deals between US and Chinese biopharma companies hit record highs last year, a 280% increase from 2020, according to analysis by GlobalData, parent company of Pharmaceutical Technology.
Notably, China-based contract manufacturer WuXi AppTec, 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 (CDMO) had been one of five Chinese life science companies named in a previous version of BIOSECURE. However, in a separate development, the Pentagon is pushing to add Wuxi AppTec to the 1260H list, according to a report last week from Bloomberg.
BIOSECURE did not make it through the $886bn National Defense Authorisation Act for FY25, a knockback that placed it in legislative limbo. However, Trump, who championed the initiative upon its unveiling in December 2023, seemingly deprioritised the act in favour of manufacturing onshoring and drug pricing reforms during the start of his second term. However, the current version moving closer to final passage through Congress means it is firmly back on the US pharma 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.
