FDA CRL - Regeneron Pharmaceuticals, Inc.

Regeneron Pharmaceuticals, Inc. has received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA 761355) for Eylea HD (aflibercept) Injection, indicating that the application cannot be approved in its current form. The primary issue identified was non-compliance with current Good Manufacturing Practice (CGMP) regulations, specifically 21 CFR parts 210 and 211. These deficiencies were observed during a pre-license inspection of the drug product manufacturing facility, affecting the methods, facilities, and controls used for manufacturing, processing, packing, and holding the drug substance and product. To achieve approval, Regeneron must satisfactorily address these manufacturing observations. Additionally, the FDA requires a resubmission of the proposed proprietary name, a comprehensive safety update, and real-world shipping studies for the final drug product under worst-case conditions to confirm product quality and sterility. Regeneron has one year to resubmit a complete response that fully addresses all identified deficiencies.