FDA Selects Eli Lilly, Regeneron Among First Seven Companies for PreCheck Manufacturing Pilot Program
核心洞察
The FDA selected Eli Lilly, Regeneron, Amneal, Cellares (搜索), Fujifilm Biotechnologies (搜索), Kriya Therapeutics (搜索), and Kyowa Kirin for its new PreCheck pilot program aimed at accelerating domestic manufacturing facility reviews.
The program allows regulators to review new manufacturing facilities during construction, potentially saving companies up to 14 months in approval timelines.
Lilly's Lebanon, Indiana API facility for GLP-1 medicines and Regeneron's $2 billion Saratoga Springs, New York biologics site are among the selected projects.
Eli Lilly and Regeneron are among the first seven companies selected by the U.S. Food and Drug Administration for a pilot program designed to accelerate reviews of new domestic pharmaceutical manufacturing facilities, CNBC has learned.
The FDA's PreCheck pilot program will allow regulators to begin reviewing new manufacturing facilities while they are still under construction, enabling companies to identify and correct any issues early in the process. According to FDA spokesperson Benjamin Nichols, the agency estimates this could save companies up to 14 months in their facility approval timelines.
The initial cohort includes Lilly, Regeneron, Amneal, Cellares (搜索), Fujifilm Biotechnologies (搜索), Kriya Therapeutics (搜索), and Kyowa Kirin — ranging from the most valuable healthcare company in the world to closely held biotechs developing gene therapies. The majority of participants plan to manufacture biologic drugs or genetic medicines, which involve significantly more complex manufacturing processes than traditional small-molecule pills.
Program Structure and Eligibility
To qualify for the PreCheck program, companies needed to build a new manufacturing facility capable of producing drugs that would address a market supply gap or improve access to therapies for unmet medical needs. Only drugs that rely on the selected facility will be covered by the program.
The initiative features two components: facility readiness, in which the FDA provides technical guidance before a site opens, and application submission, where participants receive more hands-on feedback from the agency along with expedited inspections and facility evaluations. The FDA said it received more than 80 requests to participate in the pilot phase.
Selected Facilities and Therapeutic Focus
Lilly's involvement centers on its Lebanon, Indiana, active pharmaceutical ingredient (API) plant for existing and future medicines, including the main ingredients of GLP-1 pills and shots. The company recently disclosed that the site would benefit from a $4.5 billion investment on top of a $27 billion program announced last year. Lilly stated it is "evaluating how PreCheck and related regulatory improvements may impact the facility's timeline and will continue to work closely with FDA to support the program's success."
Regeneron's $2 billion Saratoga Springs, New York, site — announced last fall — will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics. Regeneron CEO Leonard Schleifer said the company has invested in U.S. biologics manufacturing and advocated for increased focus on domestic production of medicines. "We're 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 America's biopharmaceutical industry," Schleifer said.
Fujifilm Biotechnologies (搜索)' facility in Holly Springs, North Carolina, is already operational and producing monoclonal antibodies for customers including Regeneron and Johnson & Johnson, with additional capacity expected to come online in 2027 and 2028. The company said it expects its operational readiness review before the end of the year thanks to the expedited process, and anticipates the program will allow its customers to explore faster approval pathways with the FDA.
Amneal's Long Island, New York, facility will manufacture small-molecule sterile liquid products for pain management, respiratory, and ophthalmic diseases. Cellares (搜索) is entering a plant in Bridgewater, New Jersey, focused on cell-based gene therapy products for oncology and hematology indications. The remaining three participants — all located in North Carolina — include Kriya Therapeutics (搜索)' Durham unit for AAV-based gene therapy products and Kyowa Kirin's Sanford plant for biotechnology drug substances targeting rare diseases.
Policy Context
Producing more drugs domestically has been a priority for the Trump administration. The PreCheck program is one of several measures designed to make capital investment projects easier for pharmaceutical companies in the U.S., alongside fast-track reviews for generics tested and made in domestic facilities and a priority voucher scheme for medicines deemed to be of national priority — which could cut review times from 10-12 months to a few weeks.
The FDA stated the program aims to "boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the US drug supply chain." Industry observers have suggested that smaller companies without the financial capacity to absorb significant investment risk may stand to benefit the most from the closer collaboration with regulators that PreCheck enables.