Eli Lilly, Regeneron in FDA PreCheck manufacturing program

Key Points:

• The FDA has selected seven companies, including Eli Lilly and Regeneron, for its PreCheck pilot program aimed at accelerating reviews of new domestic pharmaceutical manufacturing facilities, potentially saving up to 14 months in the approval process.
• The program allows the FDA to review manufacturing sites while under construction, focusing on facilities producing biologic drugs or genetic medicines to address market supply gaps or unmet medical needs.
• Lilly's Lebanon, Indiana facility, which will produce key ingredients for GLP-1 drugs, and Regeneron's $2 billion Saratoga Springs, New York site are among the selected facilities benefiting from early regulatory guidance and expedited inspections.
• Fujifilm Biotechnologies' Holly Springs, North Carolina facility, already producing monoclonal antibodies for clients like Regeneron and Johnson & Johnson, expects to complete its operational readiness review by year-end through the program.
• The PreCheck program includes facility readiness assessments and application submission support, fostering collaboration between manufacturers and regulators to enhance U.S. biopharmaceutical manufacturing capabilities.