Prestige Bio "Herceptin Biosimilar Demonstrates Equivalence to Original Drug in Clinical Trials"

CEO So-yeon Park of Prestige BioPharma. / Photo by Prestige BioPharma

[Asia Economy Reporter Myunghwan Lee] Prestige BioPharma announced on the 7th that the final analysis paper of the Phase 3 clinical trial of the Herceptin biosimilar 'HD201' has been published in the international cancer specialty journal 'BMC Cancer.' Prestige BioPharma explained that this paper once again demonstrated the equivalence between HD201 and the original drug Herceptin.

The final clinical analysis paper was conducted under the leadership of Professor Pivo, who was the clinical lead for Roche's Herceptin and Samsung Bioepis's biosimilar. The global Phase 3 clinical trial of HD201 was conducted from February 2018 to January 2022 in a total of 12 countries, involving 502 patients with HER2-positive breast cancer. According to the paper, the 3-year event-free survival rate of patients who received the drug was 85.6% in the HD201 group and 84.9% in the original drug group. The 3-year overall survival rate was also 95.6% in the HD201 group and 96.0% in the original drug group.

Based on this, the company plans to accelerate preparations for the U.S. Food and Drug Administration (FDA) approval application.

Previously, in July 2021, Prestige BioPharma published the results of the bridging clinical trial of HD201 in the international journal 'Pharmacology Research & Perspectives,' confirming that the Phase 1 clinical results of HD201 could be equivalently applied to both the original drugs sold in the U.S. and Europe. Additionally, through the interim analysis results of the Phase 3 clinical trial published in March last year in the American Medical Association's oncology journal 'JAMA Oncology,' equivalence with the original drug was demonstrated in terms of complete response rate and objective response rate.

Park Soyeon, CEO of Prestige BioPharma, stated, "Based on the high comparative equivalence with the original drug, efficient production through our affiliate Prestige BioLogics, and prior experience with EMA applications, we will do our best to submit documents and respond promptly to obtain approval for product licensing as soon as possible in the U.S., Europe, Canada, Korea, and other regions worldwide."