Scienza e Tecnologia
Prestige Biopharma and Biosidus Enter Exclusive License Agreement for Tuznue® Commercialization in Latin America
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 .
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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).
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.
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.
View original content:https://www.prnewswire.co.uk/news-releases/prestige-biopharma-and-biosidus-enter-exclusive-license-agreement-for-tuznue-commercialization-in-latin-america-302626228.html