FDA CRL - Celltrion Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to CELLTRION, Inc. regarding its Biologics License Application (BLA 761377) for CT-P42, stating the application cannot be approved in its current form. A critical approvability issue is the requirement for satisfactory responses to deficiencies identified during a pre-license inspection (PLI) of a manufacturing facility. CELLTRION must ensure these responses are provided by the facility and included in their complete resubmission. Additionally, the FDA requires revisions to the prescribing information (PI) to ensure compliance with 21 CFR 201.56 and 201.57, updates to carton and container labeling, and resubmission of the conditionally acceptable proprietary name once all other issues are resolved. A comprehensive safety update is also mandated, including new clinical study data, detailed adverse event reporting, updated exposure information, a summary of worldwide safety experience, and English translations of foreign labeling. CELLTRION must address all deficiencies and resubmit the application within one year, as partial responses will not initiate a new review cycle. The product cannot be legally marketed until written approval is granted.