Prestige BioPharma's Herceptin Biosimilar, Tuznue, Receives Final Marketing Authorization from the European Commission
Tuznue's Final European Approval and its Significance
The European Commission (EC) has completed the final marketing authorization process for 'Tuznue (HD201),' Prestige BioPharma's (950210) trastuzumab biosimilar. This approval, officially confirmed on September 19, 2024, represents a significant achievement, especially after the company voluntarily withdrew its application due to manufacturing process changes in 2022 and successfully reapplied. Tuznue has demonstrated equivalent efficacy and safety compared to the originator drug, Herceptin from Roche, thereby securing the legal right to be sold in all 27 member states of the European Union.
Clinical Equivalence and Safety Verification Results
The core evidence supporting this approval comes from the TROIKA study, a global Phase 3 clinical trial conducted on HER2-positive early breast cancer patients. In the primary endpoint of the trial, the overall pathological complete response rate (tpCR) in the neoadjuvant setting was 45.0% for the Tuznue group and 48.7% for the Herceptin group, meeting the criteria for statistical equivalence. Furthermore, the event-free survival (EFS) rate, confirmed through three years of follow-up, was 85.6% for Tuznue and 84.9% for Herceptin, demonstrating no significant difference in long-term survival benefits.
European Market Strategy through Partnership with Teva
To maximize commercial success following the approval, Prestige BioPharma has entered into an exclusive license and supply agreement with Teva (TEVA) for 31 European countries. Teva will leverage its established sales network and infrastructure in Europe to drive early market penetration for Tuznue. While the specific contract amount is confidential, this deal is expected to generate significant milestone payments and royalties based on future sales performance.
Securing Price Competitiveness in the Breast Cancer Treatment Market
The global trastuzumab biosimilar market is projected to grow rapidly from approximately $6.9 billion in 2025 to $8.86 billion in 2026, making it a high-value market. Tuznue faces a challenging situation as it must compete with established biosimilars such as Herzuma from Celltrion and Kanjinti from Amgen. However, by negotiating prices with European national health authorities and achieving timely reimbursement listings in each country, Tuznue can secure a reasonable price competitiveness and capture market share, despite being a late entrant.
This European Commission approval for Tuznue signifies that Prestige BioPharma has successfully entered the global Herceptin biosimilar market, diversifying its revenue streams and completely resolving regulatory risks. The global trastuzumab market is expected to reach approximately $8.86 billion in 2026, and Tuznue will compete fiercely with existing market leaders such as Celltrion's Herzuma and Amgen's Kanjinti. The pathological complete response rate (tpCR) of 45.0% and the 3-year survival data confirmed in the Phase 3 TROIKA study demonstrate equivalent efficacy compared to other drugs and will serve as a strong reference in future hospital bidding markets in Europe. The exclusive supply agreement with Teva for 31 European countries will minimize initial marketing costs and accelerate market penetration, thereby promoting short-term royalty inflows and accelerating Prestige BioPharma's timeline to profitability in the medium to long term.
Source: EMA (ema)