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...

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