HD201

Tuznue™ (Trastuzumab Biosimilar)

Overview

  • HD201
    Trastuzumab Biosimilar (Herceptin® biosimilar)
  • Therapeutic Area: Oncology
  • Indication: Breast cancer, Gastric cancer
  • Presentations: 150mg and 440mg powder for concentrate for solution for infusion
  • Patent protected technology
  • Stage: Filing MAA to the EMA on 31 July, 2023
  • Commercial name: Tuznue™

HD201
Trastuzumab Biosimilar
Breast Cancer, Gastric Cancer

Clinical Development Program

An Overview

Protocol number
/ Study type		 Title of the study Status
TROIKA-1
(Pivotal PK similarity)		 A Double-blind, Randomized, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of
a Single Intravenous Dose of HD201 Versus EU-Herceptin and US-Herceptin in Healthy Male Subjects		 Completed
EAGLE-I-12
(PK similarity)		 A Phase I, Double-blind, Randomized, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of
a Single Intravenous Dose of HD201 and Herceptin in Healthy Male Subjects		 Completed
TROIKA
(Clinical similarity)		 A Randomized, Double-blind, Parallel-group, Equivalence, Multicentre Phase Ill trial to compare the Efficacy, Safety,
and PKs of HD201 to EU-Herceptin in Patients with HER2-positive Early Breast Cancer		 Completed

TROIKA-1

Protocol number
/ Study type		 TROIKA-1
(Picotal PK similarity)
Title of the study A Double-blind, Randomized, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties ofa Single Intravenous Dose of HD201 Versus EU-Herceptin and US-Herceptin in Healthy Male Subjects
Status Completed

EAGLE-I-12

Protocol number
/ Study type		 EAGLE-I-12
(PK similarity)
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 HD201 and Herceptin in Healthy Male Subjects
Status Completed

EAGLE-I-12

Protocol number
/ Study type		 TROIKA
(Clinical similarity)
Title of the study A Randomized, Double-blind, Parallel-group, Equivalence, Multicentre Phase Ill trial to compare the Efficacy, Safety,
and PKs of HD201 to EU-Herceptin in Patients with HER2-positive Early Breast Cancer
Status Completed

Publications

  • Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial – PubMed (nih.gov)

  • Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting