Coherus BioSciences (CHRS) Announces Submission of CHS-1701 BLA to U.S. FDA Under 351(k) Pathway
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Coherus BioSciences Submits 351(k) Biologics License Application to U.S. Food and Drug Administration for CHS-1701 (Pegfilgrastim Biosimilar Candidate)
August 9, 2016 1:54 PM EDTREDWOOD CITY, Calif., Aug. 09, 2016 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to U.S. FDA under the 351(k) pathway. Â
The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta. Â
The CHS-1701 BLA submission marks a significant milestone in our ongoing transition to a commercial company in a transformational year for Coherus as we continue to focus on execution of our... More
