Coherus BioSciences has filed of its
351(k) Biologics License Application (BLA) for its pegfilgrastim biosimilar
candidate CHS-1701 has been accepted by the U.S. Food and Drug
Administration.
The submission of the BLA is backed up by comparison data from
various types of studies, including analytical, pharmacokinetic, pharmacodynamic
and immunogenicity, that put CHS-1701 in comparison with Neulasta.
The action
date of the BLA, which is set by the biosimilar user fee act, is June 9, 2017.
FDA accepts Coherus’ BLA for CHS-1701
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