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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