EC approval of trastuzumab biosimilar Herwenda

Biosimilares/Novedades | Posted 23/01/2024 post-comment0 Post your comment

The European Commission (EC) granted marketing authorization for trastuzumab biosimilar Herwenda on 15 November 2023. The biosimilar of Herwenda is developed by EirGenix, Inc.

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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 over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers [1].

The EC approval follows a positive opinion issued on 15 September 2023 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) [2].

The positive CHMP opinion was based on the results from phase I and phase III trials. This included an 807-patient phase III trial (NCT03433313) where subjects either received the biosimilar or Herceptin in combination with the chemotherapy drug, paclitaxel. The study demonstrated that the biosimilar was non-inferior to the reference biological.

Sandoz is responsible for the worldwide commercialization of EirGenix’s Herceptin biosimilar, excluding Taiwan, China, Russia, and some Asian countries. Meanwhile, EirGenix retains the rights for development, commercialisation, and manufacturing of the biosimilar in countries not covered by Sandoz.

Europe has now approved seven trastuzumab biosimilars, including Herwenda. They are Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera and Zercepac.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 23]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of trastuzumab biosimilar Herwenda []. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 23]. Available from:

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