Eli Lilly, Regeneron in FDA PreCheck manufacturing program

Elie Lilly And Regeneron are among the first seven companies selected by the U.S. Food and Drug Administration for a pilot program designed to expedite review of new domestic pharmaceutical manufacturing facilities, CNBC has learned.

Lilly, Regeneron, AmnéalCellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin are the first companies to participate in the FDA’s PreCheck pilot program, according to FDA spokesperson Benjamin Nichols. The initiative will allow regulators to begin reviewing new manufacturing facilities while they are under construction to detect and correct any problems, which the FDA estimates could save companies up to 14 months.

Producing more drugs domestically has been a priority for the Trump administration. Early recipients range from the world’s most valuable health care company to closely held biotech companies developing gene therapies. The majority of them plan to make biological drugs or genetic drugs, which require more complex manufacturing.

To be eligible for the PreCheck program, companies had to build a new manufacturing facility capable of making drugs that would fill a supply gap in the market or improve access to therapies for unmet medical needs. Only medications that depend on the facility will be covered by the program.

For example, the FDA has selected Lilly’s Lebanon, Indiana, facility that will manufacture the main ingredients for GLP-1 pills and injections. Lilly said it is “evaluating how PreCheck and associated regulatory enhancements may impact the facility’s timeline and will continue to work closely with the FDA to support the success of the program.”

The $2 billion Saratoga Springs, New York, site announced by Regeneron last fall was also chosen. In a statement, Regeneron CEO Leonard Schleifer said Regeneron has invested in biologics manufacturing in the United States and advocated for an increased focus on domestic drug production.

“We are pleased to see programs like the FDA’s PreCheck pilot program that encourage collaboration between innovators and regulators to build next-generation manufacturing capabilities and strengthen the U.S. biopharmaceutical industry,” he said.

Another beneficiary is Fujifilm Biotechnologies’ new facility in Holly Springs, North Carolina. The contractor opened the site last year. It already manufactures monoclonal antibodies for Regeneron customers and Johnson & Johnsonand will produce them for other customers as other parts of the site open in 2027 and 2028.

The PreCheck program has two components: facility readiness, where FDA provides technical guidance to companies before the site opens, and application submission, where participants can get more hands-on feedback from FDA and expedited inspections and evaluation of facilities.

Fujifilm said it expects an operational readiness review before the end of the year through the expedited process. And the company hopes the program will allow its customers to explore faster approval pathways with the FDA.