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[Notice to shareholders] Celltrion’s Statement on CRLs from the U.S. FDA for rituximab and trastuzumab biosimilar

2018.04.06

Celltrion received a Complete Response Letters (CRLs) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for CT-P10 (rituximab), a proposed biosimilar to Rituxan® and CT-P6 (trastuzumab), a proposed biosimilar to Herceptin®.  

 

The FDA Warning Letter issued to Celltrion in January 2018 was directly related to the receipt of the CRL.

 

Celltrion is making progress addressing the concerns raised by the FDA in a Warning Letter issued in January and is committed to working with the agency to fully resolve all outstanding issues with the highest priority and urgency.

 

Celltrion is confident that the issues raised by the FDA will be resolved in a timely manner.

 

We can confirm that the resubmission will be in-place relatively soon. Then, we are expecting approvals in 6 months after resubmission according to regulatory timeline.

 

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