FDA CRL - Celltrion Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to CELLTRION, Inc. for its Biologics License Application (BLA 761377), indicating that the application cannot be approved in its present form. The regulatory framework for this decision is based on deficiencies identified during facility inspections, product quality concerns, and incomplete labeling information. Key issues include multiple manufacturing facilities requiring satisfactory responses to FDA Form 483 observations from Current Good Manufacturing Practice (CGMP) and pre-license inspections. Re-inspections may be necessary to confirm compliance. Product quality concerns were also noted, specifically regarding changes in the stoppering process. Required actions involve addressing all facility inspection deficiencies with the FDA office indicated on the Form 483s, ensuring CGMP compliance, and coordinating updates to the BLA as needed. CELLTRION must also submit revised prescribing information and carton/container labeling that adheres to FDA regulations (e.g., 21 CFR 201.56, 201.57, 601.14) and guidances, including structured product labeling (SPL) format. Furthermore, a comprehensive safety update is mandated, detailing nonclinical and clinical data, changes in the safety profile, and worldwide experience. The proposed proprietary name, though conditionally acceptable, must be resubmitted once all other deficiencies are resolved.