On 25 November 2025, Prestige Biopharma announced that it has entered into an exclusive license and supply agreement with Biosidus for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a variety of Latin American markets including Argentina, Mexico, Bolivia and Paraguay.
Under the agreement, Biosidus will have exclusive rights to market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, while Prestige will be responsible for the production and supply 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.
The agreement follows a separate licence agreement entered into by Prestige and Teva for the commercialisation of Tuznue® across a majority of European markets. Under that agreement, Teva is responsible for marketing and distribution Tuznue® in a majority of European markets, while Prestige is responsible for production and supply, also through its EU-GMP-certified facilities.
Tuznue® was approved by the European Medicines Agency in September 2024, following the adoption of a positive opinion in July 2024, which landmarked the first major adoption of the product on the global stage.