Celltrion Completes Resubmission for Biosimilar Candidate to FDA for Review
https://www.businesswire.com/news/home/20180529006382/en/
INCHEON, South Korea--(BUSINESS WIRE)--May 29, 2018--Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P10 (rituximab), a proposed mAb biosimilar to Rituxan ®.
Additionally, Celltrion plans on making a resubmission for the approval of CT-P6, a proposed biosimilar to Herceptin ® in June. In accordance with FDA regulations, the approval procedure will be usually finalized within six months from the resubmission, so Celltrion expects the approval for the U.S. market of the two proposed biosimilars within this year.