SINGAPORE - Prestige Biopharma, a biopharmaceutical company specializing in antibody therapeutics, today announced an exclusive license and supply agreement with Biosidus, a biotechnology company headquartered in Buenos Aires, Argentina, with decades of experience in biosimilar development and commercialization, for the commercialization of Tuznue® (trastuzumab) across Latin American markets, including Argentina, Mexico, Bolivia, and Paraguay.

Tuznue® is a biosimilar to Herceptin® (trastuzumab), approved for the treatment of breast cancer and metastatic gastric cancer. Prestige Biopharma received European Commission (EC) marketing authorization for Tuznue® in September 2024. This approval marks a major milestone for the company's biosimilar portfolio, signaling progress in expanding access to cost-effective treatments across key global markets.

Under the agreement, Biosidus secures exclusive rights to market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, leveraging its extensive commercial network and deep expertise in biosimilar adoption. Prestige Biopharma will be responsible for the production and supply of the drug substance through its EU-GMP-certified, high-tech facility equipped with advanced single-use technology. Biosidus will manufacture the drug product at its facility in Buenos Aires, Argentina, from which it will supply the product to the local market, and export the product to the markets of Mexico, Paraguay and Bolivia.

Lisa S. Park, CEO of Prestige BioPharma, commented: "We are pleased to announce our strategic partnership with Biosidus for Argentina and other key markets in Latin America. With its proven track record and deep regional expertise, Biosidus represents an ideal partner for the successful manufacturing and commercialization of our lead biosimilar. We are confident that this collaboration will further enhance the global value and reach of our biosimilar portfolio."

Mariano Elizalde, CEO of Biosidus, said: "We are proud to partner with Prestige Biopharma to introduce Tuznue® in selected markets across Latin America. This agreement strengthens our Biosimilars portfolio and our commitment to expand access to biotechnological medicines in Latin America. Together with Prestige Biopharma, we are confident in offering patients and healthcare professionals a quality and affordable therapeutic option".