Posted by Michael Wonder on 17 May 2018
U.S. FDA accepts and acknowledges Coherus BioSciences biologics license application of CHS-1701 (pegfilgrastim biosimilar candidate) for review
14 May 2018 - Coherus BioSciences today announced the U.S. FDA has accepted and acknowledged for review the re-submission of the biologics license application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate.
In the communication, FDA indicated that they consider the resubmission a complete response to their 9 June 2017 action letter. FDA provided a biosimilar user fee act action date of 3 November 2018.
The letter did not indicate the need to prepare for an advisory committee meeting.
