Breaking News, Trials & Filings

Coherus Finalizes CHS-1701 BLA Enabling Clinical Program

Also initiates pharmacokinetic and pharmacodynamic study

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Coherus BioSciences, Inc., a global biosimilars company with late-stage clinical products, has finalized the Biologics License Application (BLA) enabling clinical program for CHS-1701, a pegfilgrastim biosimilar candidate, and initiated a pivotal pharmacokinetics and pharmacodynamics (PK/PD) study pursuant to feedback received from the U.S. Food and Drug Administration (FDA) on the CHS-1701 development plan. An additional immunogenicity study is planned in healthy volunteers pursuant to this BLA and is projected to be concluded in 2015 to support submission of the 351(k) (biosimilar) license application for CHS-1701 in Q4 2015 or Q1 2016.

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