FDA CRL - Coherus Biosciences, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Coherus BioSciences, Inc. regarding its Biologics License Application (BLA) for toripalimab-tpzi injection, originally submitted in August 2021. The FDA determined that the application cannot be approved in its present form, citing significant product quality deficiencies related to manufacturing controls.

The primary concern highlighted was that the manufacturing control strategy for toripalimab did not align with current industry standards and ICH Q5A guidelines. Specifically, the FDA identified a lack of adventitious virus testing for unprocessed bulks (UPBs) in manufacturing processes for non-U.S. market products that share common equipment and materials with toripalimab intended for the U.S. market. This omission poses a risk of cross-contamination and potential manufacturing facility disruptions.

To address these issues, Coherus BioSciences is required to implement a comprehensive virus testing program for UPBs for all products sharing manufacturing equipment and materials, submitting relevant change control reports. Further actions include mitigating contamination risks by replacing high-risk multi-use materials and sterilizing shared product-contact equipment. The company must also confirm the availability of drug product manufactured after these corrective measures for review, provide a detailed rationale for the revised control strategy, update the Medication Guide on labeling, and submit a comprehensive safety update.