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[Notice to shareholders] Notification of resubmission for biosimilar candidate CT-P10 for FDA review

2018.05.30

Celltrion has recently made its resubmission to the U.S. FDA for approval of CT-P10 (rituximab), a proposed biosimilar to Rituxan®. We thus inform you that U.S. FDA has officially resumed the approval procedure for CT-P10 (rituximab) 

Celltrion had submitted Biologics License Applications (BLA) for CT-P10 (rituximab) and CT-P6 (trastuzumab), a proposed biosimilar to Herceptin®, to the FDA in April and May of last year, respectively. However, Celltrion received CRLs (Complete Response Letter) from FDA recently.

Afterwards, Celltrion has made progress in addressing the concerns raised by the FDA in the 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.

Thus, the FDA has recently notified Celltrion of its re-inspection schedule for our regular audit results, and separately from this process, it has confirmed that the approval procedure for the two proposed biosimilars will resume upon resubmission.

In June, Celltrion plans on making a resubmission for approval of CT-P6 (trastuzumab). In accordance with FDA regulations, the approval procedure will be usually finalized within six months from the resubmission, so Celltrion hopes to obtain the approval for the U.S. sale of the two proposed biosimilars within this year.

Celltrion will be doing the best to ensure the U.S. approval of the two proposed biosimilars.

Thank you very much.

 

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