Teva Partners with Prestige Biopharma to Commercialize Tuznue Trastuzumab Biosimilar Across Europe
核心洞察
Teva Pharmaceuticals has entered into a license and supply agreement with Prestige Biopharma (搜索) to commercialize Tuznue, a biosimilar to Herceptin (trastuzumab), across a majority of European markets.
Tuznue received European Commission marketing authorization in September 2024 and is approved for treating HER2 (搜索)-positive breast cancer and metastatic gastric cancer.
The partnership leverages Teva's extensive European commercial network while Prestige Biopharma (搜索) handles production through its EU-GMP-certified facilities with 154,000-liter capacity.
Teva Pharmaceuticals International GmbH has secured a strategic partnership with Prestige Biopharma (搜索) to bring the trastuzumab biosimilar Tuznue to European cancer patients, marking a significant expansion in the biosimilar oncology market. The license and supply agreement, announced October 20, 2025, grants Teva commercialization rights across a majority of European markets for the Herceptin biosimilar.
Regulatory Milestone and Market Access
Tuznue received European Commission marketing authorization in September 2024, clearing the path for its commercial launch. The biosimilar is approved for treating patients with HER2 (搜索)-positive metastatic breast cancer, HER2-positive early breast cancer, and HER2-positive metastatic gastric cancer. According to the companies, Tuznue demonstrates similar efficacy and safety profiles to the original branded medication while offering a more cost-effective therapeutic alternative.
Strategic Partnership Structure
Under the agreement terms, Teva will leverage its extensive commercial network and proven biosimilar expertise to market and distribute Tuznue across European markets. Prestige Biopharma (搜索) retains responsibility for production and supply through its EU-GMP-certified manufacturing facilities in Korea, which feature advanced single-use technology and maintain a production capacity of 154,000 liters.
"We are passionate about the future of biosimilars and the value they bring to patients and healthcare systems," said Richard Daniell, Executive Vice President, European Commercial, Teva. "Our deep commercial experience in biosimilars and broad sales and marketing reach across Europe enables us to bring critical medicines to patients."
Pipeline Implications
The collaboration extends beyond Tuznue, with potential implications for Prestige Biopharma (搜索)'s broader biosimilar development program. Lisa Park, CEO of Prestige Biopharma, indicated that Teva's market reach will accelerate development of the company's biosimilar pipeline, which includes bevacizumab and 14 additional candidates currently in development.
"This collaboration is a significant step in establishing Prestige Biopharma (搜索) as a global biopharmaceutical leader," Park stated. "Teva's extensive market reach will drive the successful launch of Tuznue while accelerating the development of our broader biosimilar pipeline."
Company Positioning
Established in 2015 in Singapore, Prestige Biopharma (搜索) has built a diversified portfolio that includes both biosimilars referencing blockbuster drugs and a first-in-class antibody drug in clinical development. The company's dedicated GMP manufacturing facility in Korea positions it as a significant player in the Asian biosimilar manufacturing landscape.
For Teva, the agreement aligns with the company's Pivot to Growth strategy, which emphasizes profitable commercialization of its biosimilar portfolio through both organic growth and business development initiatives. The partnership represents Teva's continued commitment to expanding access to complex generic medicines and biosimilars across global markets.