FDA accepts Coherus’ BLA for CHS-1701

The FDA has accepted Coherus' BLA for its investigational biosimilar candidate.
The FDA has accepted Coherus' BLA for its investigational biosimilar candidate. | File image
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.
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Organizations in this story

Coherus BioSciences, Inc. 333 Twin Dolphin Dr Redwood City, CA - 94065