FDA CRL - Celltrion Inc.

The FDA issued a Complete Response Letter (CRL) to CELLTRION, Inc. for its Biologics License Application (BLA) 761088 for CT-P10, a proposed biosimilar to US-licensed Rituxan. The application cannot be approved in its present form due to unresolved deficiencies identified during a recent manufacturing facility inspection, significant clinical study concerns, and numerous product quality issues.