HD204

Vasforda™ (Bevacizumab Biosimilar)

Overview

  • HD204
    Bevacizumab Biosimilar (Avastin® Biosimilar)
  • Therapeutic Area: Oncology
  • Indication: Non-small cell lung cancer, colorectal cancer, etc
  • Presentations:400mg in studies, 100mg planned to file
  • Patent protected technology
  • Status: Global phase 3 clinical trial- Recruiting completed.
  • Commercial name: Vasforda™

HD204
Bevacizumab Biosimilar
Non-small cell lung cancer, colorectal cancer, etc.

Clinical Development Program

An Overview

Protocol number
/ Study type		 Title of the study Status
SAMSON-1 A Phase I, double-blind, randomized, parallel group study to demonstrate the equivalent pharmacokinetic Properties of
a Single Intravenous Dose of HD204, US-Avastin® and EU-Avastin® in Healthy Male Subjects		 Completed
SAMSON-II
 A randomized, double-blind, parallel group, equivalence, Multi-centre Phase III trial to compare the efficacy, safety, pharmacokinetics
and immunogenicity of HD204 to Avastin® in patients with metastatic or recurrent Non-squamous Non-small Cell Lung Cancer		 Ongoing

SAMSON-1

Protocol number
/ Study type		 SAMSON-1
Title of the study A Phase I, double-blind, randomized, parallel group study to demonstrate the equivalent pharmacokinetic Properties of
a Single Intravenous Dose of HD204, US-Avastin® and EU-Avastin® in Healthy Male Subjects
Status Completed

SAMSON-Ⅱ

Protocol number
/ Study type		 SAMSON-II
Title of the study A randomized, double-blind, parallel group, equivalence, Multi-centre Phase III trial to compare the efficacy, safety, pharmacokinetics
and immunogenicity of HD204 to Avastin® in patients with metastatic or recurrent Non-squamous Non-small Cell Lung Cancer
Status Ongoing

Publications

  • A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab