Prestige Biopharma Publishes Preclinical Study of Biosimilar Tuznue® in SCI Journal Drug in R&D

Prestige Biopharma Publishes Preclinical Study of Biosimilar Tuznue® in SCI Journal Drug in R&D

(https://pubmed.ncbi.nlm.nih.gov/40175862/ )

Prestige Biopharma (KRX: 950210) announced that a preclinical comparative study of its trastuzumab biosimilar Tuznue® has been published in the SCI-indexed international journal Drug in R&D.

This marks the first time Prestige Biopharma has published a preclinical research paper related to its biosimilar development. The publication includes contributions from Chairwoman Soyeon Park and experts in manufacturing and quality control (CMC) as co-authors. The study was led by Professor Xavier Pivot, a globally recognized biosimilar expert who previously led the global Phase 3 clinical trials of Tuznue®.

By publishing the study, the company aims to demonstrate the high level of similarity between Tuznue® and the reference product Herceptin from the preclinical stage, reinforcing confidence in the product ahead of its global market expansion.

The study evaluates the analytical and functional similarity between Tuznue® and the original trastuzumab product through comprehensive assessments. According to the results, the biosimilar met equivalence criteria across key quality attributes based on the risk-based statistical analysis framework (Tier 1–3) recommended by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key parameters examined in the study included HER2 binding activity, antibody-dependent cellular cytotoxicity (ADCC), and Fc receptor binding, all of which demonstrated comparable performance between Tuznue® and the reference product.

Drug in R&D is an SCI(E)-indexed international journal that focuses on early-stage pharmaceutical development research. The journal frequently publishes studies aligned with regulatory standards from the EMA and is widely referenced by European researchers. In the United States, such publications are also often used as supporting evidence during pre-submission consultations with the FDA.

Prestige Biopharma noted that the publication highlights the company’s strong capabilities in CMC strategy and analytical characterization. Rather than simply replicating the reference product, the company implemented a detailed analytical characterization approach to design and reproduce the product’s attributes through carefully optimized manufacturing processes.

A company representative stated that the publication represents more than a scientific milestone, emphasizing that it demonstrates Prestige Biopharma’s globally competitive capabilities in CMC and clinical development. The company expects the study to further strengthen confidence in Tuznue® as it prepares for commercial launch in the European market.

Source: Edaily (https://www.edaily.co.kr/News/Read?newsId=02282886642136776&mediaCodeNo=257&OutLnkChk=Y)