Posted by Michael Wonder on 30 May 2018
Celltrion completes resubmission for biosimilar candidate to FDA for review
30 May 2018 - U.S. FDA notified Celltrion of its re-inspection schedule regarding cGMP regular audit.
Celltrion has made a resubmission to the FDA 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.
