U.S. Food and Drug Administration Accepts and Acknowledges Coherus BioSciences Biologics License Application of CHS-1701 (Pegfilgrastim Biosimilar Candidate) for Review
Coherus BioSciences, Inc. (CHRS)
Last coherus biosciences, inc. earnings: 2/27 04:01 pm
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Source: GlobeNewswire
REDWOOD CITY, Calif., May 14, 2018 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the U.S. Food and Drug Administration (FDA) has accepted and acknowledged for review the re-submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. In the communication, FDA indicated that they consider the resubmission a complete response to their June 9, 2017 action letter. FDA provided a biosimilar user fee act (BSUFA) action date of November 3, 2018. The letter did not indicate the need to prepare for an advisory committee meeting. “We appreciate FDA’s prompt action on our file and look forward to working with them on the review,” said Denny Lanfear, President and CEO of Coherus BioSciences. “We believe that CHS-1701 is well-positioned to deliver greater access to oncology patients and savings to the healthcare system. We are continuing to make good progress in building inventory of CHS-1701 and in prep
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