Research & Development
Celltrion completes CT-P6 approval re-submission to US FDA
19 June 2018 -

South Korea-based Celltrion has completed a re-submission to the US Food and Drug Administration (FDA) seeking approval for CT-P6, a proposed mAb biosimilar to cancer drug Herceptin.

It was reported yesterday that the company had submitted its abbreviated Biologics License Applications(aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last year, respectively. However, it received complete response letters from the FDA related to the warning letter issued by the FDA in January 2018, related to the manufacturing facility in Incheon, South Korea.

The firm had completed the resubmission for the approval of CT-P10, a proposed biosimilar to Rituxan (rituximab) last month. In accordance with FDA regulations, the approval procedure will be usually finalised within six months from the resubmission, so the company expects the approval for the United States market of the two proposed biosimilars within this calendar year.

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