Prestige Biopharma and Biosidus Enter Exclusive License Agreement for Tuznue® Commercialization in Latin America

SINGAPORE, Nov. 26, 2025 /PRNewswire/ -- 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".

About Tuznue®

Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC).

About Prestige Biopharma

Established in 2015 in Singapore, Prestige Biopharma is a biopharmaceutical company with a diversified portfolio. Among its many pipelines, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development. Notably, the first-in-class PAUF-based antibody drug, ulenistamab, has received Orphan Drug Designation from the U.S. FDA, the European EMA, and the Korean MFDS, along with Fast Track Designation from the U.S. FDA. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic.

About Biosidus

Biosidus is an Argentine company, a pioneer in biotechnology, which over the last 42 years has achieved a leadership position in Latin America and a growing share in other emerging markets in Asia, Africa and Eastern Europe, developing, producing and marketing biopharmaceuticals of the highest quality at affordable prices.

SOURCE Prestige Biopharma Limited