Lawmakers are proposing a new effort to strengthen biopharma manufacturing in the U.S., leveraging a bill that seeks to create a dedicated center of excellence in the country.
The bill, dubbed the “Biomanufacturing Excellence Act of 2025,” was introduced on Nov. 18 to the House Committee on Science, Space and Technology by a bipartisan group of lawmakers, including Rep. Chrissy Houlahan, D-Pa., Rep. Jim Baird, R-Ind., Rep. Deborah Ross, D-N.C., and Rep. David Rouzer, R-N.C.
Sen. Chris Coons, D-Del., and Sen. Ted Budd, R-N.C., proposed the same bill in the Senate.
In essence, the legislation seeks to reduce U.S. dependence on foreign supply chains and to ensure a smoother road to commercialization through a national public-private biopharmaceutical manufacturing center of excellence. The production hub would be designed to “facilitate and accelerate manufacturing innovation, support good manufacturing practices” and provide training for workers to “bolster talent” throughout the industry, according to the bill.
Importantly, the bill puts a focus on boosting regulatory understanding of innovative manufacturing methods, especially as they pertain to products that could be important to U.S. national security, health security, and economic security, the lawmakers noted in a press release. Drugmakers would be able to use the center to test manufacturing methods and engage with regulators in an up-to-code environment.
“Biotechnology is rapidly reshaping national defense, health security, and our economy’s resilience,” Rouzer said in the release. “By supporting public-private collaboration and growing our domestic manufacturing base, this legislation ensures the United States can remain competitive, reduce reliance on foreign supply chains, and equip the next generation of biotechnology leaders to drive our nation forward.”
The concept was initially drawn out in an April report (PDF) from the National Security Commission on Emerging Biotechnology (NSCEB), which advised Congress to dole out $120 million to establish a center of excellence that could, ideally, “bring together companies, academics and government scientists to advance innovative biopharmaceutical manufacturing.”
“The biopharmaceutical sector needs manufacturing innovations, given how expensive and difficult biopharmaceuticals are to produce,” the report explains. “The sector needs to advance their manufacturing processes and catalyze full-scale production in the United States, especially to solve future technical challenges.”
NSCEB, a legislative commission that was tasked to create a set of biotechnology policy recommendations in 2022, specifically calls out products “important to U.S. national security” such as gene therapies and antibodies, which could benefit from manufacturing innovation in the U.S.
In its report, the commission further warned that the U.S. “must take swift action in the next three years” or it risks falling behind in the biotechnology sector. Specifically, China is “quickly ascending to biotechnology dominance,” and the U.S. risks “falling behind," the report cautioned.
The biomanufacturing center proposal comes on the heels of another NSCEB report (PDF) last month, in which the group doubled down on its warnings about the threat of competition from China.
Similar legislation has been floated before amid the race to strengthen the U.S.’s manufacturing infrastructure and counter competitive threats from China. In June, a group of senators introduced the Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act to address drug shortages, improve preparedness and reduce national security threats that could arise from an overdependence on China and other countries for critical medicines and their key ingredients.
Then, in October, the Senate voted in favor of a new iteration of the failed Biosecure Act, which seeks to prevent companies reliant on federal contracts and funding from working with certain Chinese biotechs of concern, while also preventing select Chinese companies from accessing U.S. government funding.
Meanwhile, President Donald Trump’s trade policies have prompted a swell of U.S. investments across the industry. Specifically, 2025 pledges from major drugmakers for investment projects over the next five years totals more than $370 billion, according to a new fourth-quarter market trend report from contractor and construction manager DPR Construction.