Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers. The originator product, Herceptin, is sold by Roche/Genentech [1].

Tuznue is approved for the treatment of breast cancer and metastatic gastric cancer. Prestige Biopharma received the European Commission (EC) marketing authorization for Tuznue in September 2024 [2, 3]. This came after the product first received the EC negative opinion in 2022, due to product ‘drift’ which surrounded changes in the manufacturing process of Tuznue during the phase III study of the biosimilar. At the time, the company argued that some of these changes were made in response to changes in the manufacturing of the originator, Herceptin [3]. 

Under the terms of the license and supply agreement, Teva has the rights to market and distribute Tuznue in a majority of European markets. Prestige Biopharma is responsible for production and supply through its EU-GMP-certified, high-tech facilities equipped with advanced single-use technology.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 4]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-trastuzumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA approved a record 28 biosimilars in 2024 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 4]. Available from: www.gabionline.net/reports/ema-approved-a-record-28-biosimilars-in-2024
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 4]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
4. GaBI Online - Generics and Biosimilars Initiative. EMA authorizations: CRO generics suspended and Herceptin biosimilar refused [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 4]. Available from: www.gabionline.net/pharma-news/ema-authorizations-cro-generics-suspended-and-herceptin-biosimilar-refused

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