Prestige Biopharma said on Thursday that it published the phase 3 multinational clinical results for its Herceptin (ingredient: trastuzumab) biosimilar, HD201(brand name: Tuznue) in the BMC Cancer journal. The company plans to seek FDA approval.

HD-201 is the company’s first biosimilar with indications for breast cancer and metastatic gastric cancer. Genentech, a subsidiary of Roche, is the owner of the original drug formulation.

The global phase 3 clinical trial of HD201 was led by Professor Xavier Pivot at Institute of Cancer in France who is a world authority on biosimilar research. 

The study compared and analyzed the HD201 administration group and the original drug administration group in a randomized manner on 502 HER2-positive breast cancer patients in a total of 12 countries from February 2018 to January 2022.

After monitoring the long-term efficacy and safety of HD201 for approximately 37.7 months, the three-year event-free survival rate of patients receiving the drug was 85.6 percent in the HD201 group and 84.9 percent in the original drug group. 

Additionally, the overall survival rate for the same period was also 95.6 percent in the HD201 group and 96.0 percent in the original drug group, proving comparative equivalence.

Previous studies also proved the biosimilar’s equivalence with complete remission rate and objective response rate indicators in intermediate phase 3 clinical results published in the JAMA Oncology journal in March last year.

"This final analysis paper of the long-term phase 3 clinical data has once again proven the superiority of HD201,” Prestige Biopharma CEO Park So-yeon said. “Based on the high comparative equivalence with the original drug, we will do our best to submit market authorization documents to regulatory agencies in the U.S., Europe, Canada, and Korea.”