Prestige Biopharma and Biosidus Forge Exclusive License Agreement for Tuznue® Biosimilar Commercialization Across Latin America
Wednesday, November 26, 2025
Prestige Biopharma, a leading Singapore-based biopharmaceutical company specializing in antibody therapeutics, announced on November 26, 2025, a significant step in its international expansion strategy via an exclusive license and supply agreement with Biosidus, a biotechnology company headquartered in Buenos Aires, Argentina. This agreement centers on the commercialization of Tuyznue® (trastuzumab), Prestige's flagship biosimilar product, across key Latin American markets—a collaboration poised to widen access to affordable therapies in oncology and highlight Asia's rising influence in global biopharma partnerships.
Tuznue® is a biosimilar version of Herceptin® (trastuzumab), a well-established treatment for HER2-positive metastatic and early breast cancer, as well as metastatic gastric cancer. Having obtained European Commission (EC) marketing authorization in September 2024, Tuznue® stands at the forefront of Prestige Biopharma's biosimilars portfolio, aiming to offer cost-effective yet high-quality therapeutic alternatives for cancer patients globally. This partnership enables Biosidus to exclusively market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, using its extensive regional commercial network and expertise in biosimilar adoption.
Under the agreement, while Prestige Biopharma will be responsible for the manufacture of the drug substance at its EU-GMP-certified and technologically advanced facility, Biosidus will localize the final drug product manufacturing in Buenos Aires. The product will not only address local demand but also serve as an export supply hub for broader Latin American markets, ensuring efficient and compliant distribution. This partnership also demonstrates how Asian biopharma manufacturers are leveraging robust manufacturing capabilities and international regulatory experience to drive biosimilar access in emerging economies—a strategy that is increasingly relevant amid intensified global competition and regulatory complexity in the biosimilars segment.
The CEOs of both companies expressed confidence that this collaboration would enrich their biosimilars portfolios, boost regional market access, and ultimately expand healthcare choices for clinicians and health authorities. Lisa S. Park, CEO of Prestige Biopharma, highlighted Biosidus's proven track record and deep regional understanding as critical success factors, aiming for seamless product adoption and lifecycle management in new markets. Similarly, Mariano Elizalde, CEO of Biosidus, noted that the agreement strengthens the company’s commitment to quality and affordability.
Tuznue® has undergone rigorous regulatory review to demonstrate equivalence in safety, efficacy, and immunogenicity to the original reference product. Its inclusion in national cancer treatment programs is expected to accelerate as health systems in Latin America seek to optimize budgets while maintaining care standards. The agreement's framework combines Prestige Biopharma's experience in biologics manufacturing with Biosidus’s market access infrastructure, exemplifying cross-border collaboration and knowledge transfer, increasingly characteristic of Asia-LATAM biopharma expansion efforts. This model offers valuable insights for pharma executives seeking to address both regulatory and commercial challenges in emerging markets, emphasizing the necessity for partnerships grounded in technology sharing, regional compliance, and end-to-end supply chain management.
Established in 2015, Prestige Biopharma continues to advance a diversified pipeline, including first-in-class antibodies and biosimilars targeting blockbuster drugs. Its PAUF-based antibody drug, ulenistamab, has received orphan drug and fast-track designations from the U.S. FDA, EMA, and Korean MFDS, with clinical trials spanning the United States, Europe, and Asia. Biosidus, with over 42 years of experience, has built a reputation in Latin America and other emerging markets for developing and producing high-quality, affordable biopharmaceuticals—a background that complements Prestige Biopharma’s ambitions for biosimilar leadership.
This alliance signals the growing trend of Asia-headquartered biopharma companies forming strategic ties with international partners, leveraging scientific innovation and manufacturing excellence from Asia to support emerging markets worldwide. As more Asian biosimilars achieve regulatory milestones and roll out through local partnerships, the broader business lesson centers on the importance of global reach, agility in regulatory navigation, and alignment with regional partners who possess nuanced market intelligence and established supply chains.
For the B2B audience—including pharma executives, drug manufacturers, and R&D strategists—this development underscores how cross-regional licensing deals and technology transfer agreements remain pivotal tools for expanding biosimilar access and driving growth outside core Asian territories. It also illustrates how next-generation biosimilars can be commercialized through collaborations that balance rigorous quality controls and regionally attuned market approaches, setting a template for future Asia-led biopharma expansion.
