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A Three-Way Pharmacokinetic (PK) Study of a Bevacizumab Biosimilar Candidate

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Trial Profile

A Three-Way Pharmacokinetic (PK) Study of a Bevacizumab Biosimilar Candidate

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 11 Aug 2020

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At a glance

  • Drugs Bevacizumab (Primary)
  • Indications Unspecified
  • Focus Pharmacokinetics; Registrational
  • Sponsors Coherus Biosciences

    • Most Recent Events

    • 11 Aug 2020 New trial record
    • 06 Aug 2020 According to a Coherus BioSciences media release, the company expects to advance the companys biosimilar candidate to Avastin (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, depending on the outcome and the timing of required interactions with the FDA in completing this three-way pharmacokinetic (PK) study, as well as completing additional analytical similarity exercises.

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