Prestige Biopharma Receives European Commission Approval for Herceptin Biosimilar Tuznue®

Prestige Biopharma Receives European Commission Approval for Herceptin Biosimilar Tuznue®

Prestige Biopharma (KRX: 950210, Chairwoman: Soyeon Park), a biopharmaceutical company specializing in antibody therapeutics, announced on the 23rd that the European Commission (EC) has granted marketing authorization for its Herceptin biosimilar Tuznue® (pipeline name: HD201, generic name: trastuzumab).

The approval was granted less than two months after the positive recommendation issued on July 26 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). With this authorization, Tuznue® officially enters the global trastuzumab market, which is estimated at approximately KRW 5.5 trillion annually, as a biosimilar treatment for breast cancer and metastatic gastric cancer.

Prestige Biopharma’s marketing authorization follows the CHMP recommendation announced earlier in July and marks the third approval among Korean companies after Celltrion and Samsung Bioepis. The company noted that final regulatory approvals for biosimilars are achieved only by a limited number of players with strong clinical development capabilities and regulatory filing expertise.

Building on the successful approval of Tuznue®, Prestige Biopharma plans to accelerate preparations for regulatory submission of its Avastin biosimilar HD204, for which Phase 3 clinical data analysis is currently underway.

Following the final approval, the company will receive milestone payments from its global pharmaceutical partner under an existing licensing agreement. Tuznue® represents the first commercialized pipeline product since the founding of Prestige Biopharma, and the company expects revenues to begin materializing once product orders commence following the launch.

Potential commercialization partners in Europe are expected to include major global pharmaceutical companies capable of rapidly penetrating the trastuzumab biosimilar market. Chairwoman Soyeon Park is also scheduled to hold related meetings during CPHI Milan 2024, the global pharmaceutical exhibition taking place in Milan, Italy, from October 8 to 10.

Soyeon Park, Chairwoman of Prestige Biopharma, said, “Our full value chain strategy enables strong price competitiveness, while our global partners’ commercial capabilities will help drive market share once Tuznue® launches commercially. Leveraging the regulatory experience gained from securing European approval for Tuznue®, we will accelerate development of our 15 follow-on biosimilar pipelines and continue growing into a leading global biopharmaceutical company.”

Source: PharmNews (https://www.pharmnews.com/news/articleView.html?idxno=250628)