Prestige Biopharma Confirms HD201 EMA Pre-Meeting... Officially Begins European Marketing Authorization Application Process

Prestige BioPharma (CEO So-Yeon Park) announced on the 4th that it has received a response scheduling a pre-meeting for the marketing authorization review of the Herceptin biosimilar ‘HD201 (Tuznue)’ applied to the European Medicines Agency (EMA) on the 17th. This meeting marks the beginning of Prestige BioPharma’s re-challenge following the voluntary withdrawal of the marketing authorization application last September, during which the contentious issues that showed differences in opinion with the EMA will be thoroughly reviewed once again. Prestige BioPharma plans to proceed with the formal marketing authorization application based on the EMA’s feedback from the pre-meeting.

The key issue in this pre-meeting is the equivalence analysis criteria between the clinical batch and the commercial batch, on which the EMA had previously expressed negative opinions. HD201 demonstrated high biological similarity and comparative equivalence with the reference drug in the Phase 3 clinical trial results, and its excellence was recognized by being published in the prestigious international oncology journal ‘BMC (BioMed Central) Cancer’ last February. Therefore, despite the withdrawal of the authorization application, no additional clinical trials were conducted, but additional validation of some analytical methods was performed.

Internally, Prestige BioPharma has completed additional testing and analysis work to meet the equivalence analysis criteria desired by the EMA’s Committee for Medicinal Products for Human Use (CHMP), and plans to ensure there are no disagreements on the evaluation criteria through close exchanges of opinions with the EMA during this pre-meeting. Having clearly identified the doubts regarding the analytical part during the previous re-examination process, the goal for this reapplication process is to obtain marketing approval through meticulous supplementation of data.

So-Yeon Park, Chairman of Prestige BioPharma, stated, “Although the entry into the European market was delayed during last year’s EMA approval process, we are thoroughly preparing the reapplication with the belief that the quality excellence of HD201, which succeeded in Phase 3 clinical trials and underwent numerous test analyses, remains unchanged.” She added, “Once the HD201 European approval application process officially begins, the prepared U.S. FDA application will also proceed sequentially, and we will do our utmost to obtain marketing approval as quickly as possible to meet the long-awaited expectations.”

Meanwhile, Prestige BioPharma is accelerating the development of two other biosimilars and a pancreatic cancer antibody drug in addition to HD201. First, the Avastin biosimilar ‘HD204,’ currently in Phase 3 clinical trials, is undergoing global Phase 3 studies, and the Humira biosimilar ‘PBP1502’ has received approval for Phase 1 clinical trials in Europe and is underway. In particular, the pancreatic cancer antibody drug ‘PBP1510’ is conducting Phase 1/2a clinical trials in Europe and the U.S., and was designated as an FDA fast-track product last March. The company explained that while the clinical trials of its main pipelines are progressing smoothly, it plans to directly overcome market concerns, which have been compounded by the pandemic situation and various trial-and-error experiences, through the first marketing authorization of HD201 and the clinical success of its pipelines.