FDA CRL - Celitrion, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Celitrion, Inc. regarding its Biologics License Application (BLA 761219) for the product CT-P17, submitted under section 351(k) of the Public Health Service Act. The FDA determined the application could not be approved due to significant deficiencies observed during a recent manufacturing facility inspection. Additionally, several product quality issues require resolution. These include implementing bacterial retention limits validated by a study, revising endotoxin limits to prevent batches from meeting internal limits but failing release specifications, defining and verifying specifications for the auto-injector's end-of-injection click timing, and conducting lockout force testing on the final finished device after simulated shipping, adhering to ASTM 4169-16. To achieve approval, Celitrion must satisfactorily resolve all facility deficiencies and address the specific product quality concerns. A comprehensive safety update, incorporating new and combined clinical data, detailed adverse event information, and worldwide experience, is also required with any resubmission. The proposed proprietary name, Yuflyma, needs to be resubmitted. Celitrion has one year to submit a complete response that fully addresses all identified deficiencies; the product cannot be legally marketed until formal approval is granted.