Posted by Michael Wonder on 18 Jun 2018
Celltrion completes resubmission to FDA for proposed trastuzumab biosimilar
18 June 2018 - Celltrion made a resubmission for the U.S. FDA approval of CT-P6, a proposed biosimilar to Herceptin (trastuzumab).
Celltrion has made a resubmission to the FDA to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin (trastuzumab).
Celltrion submitted its abbreviated biologics license applications 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.
Celltrion 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 Celltrion expects the approval for the U.S. market of the two proposed biosimilars within this calendar year.
