EMA recommends approval of trastuzumab biosimilar Herwenda

Biosimilars/News | Posted 03/10/2023 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2023 that it had recommended granting of marketing authorization for the trastuzumab biosimilar Herwenda, 150 mg, for intravenous use.

Breast cancer V15J22

Sandoz’s trastuzumab biosimilar is called Herwenda and was developed by EirGenix, Inc. The positive opinion covers treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, the same indications as approved by EMA for the reference biological. 

Trastuzumab is a monoclonal antibody that binds to and inactivates the 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 originator product, Roche’s Herceptin (trastuzumab), was approved by the US Food and Drug Administration (FDA) in September 1998 and by EMA in August 2000 [2].

Pierre Bourdage, Chief Commercial Officer, Sandoz, said: ‘Breast and gastric cancers are among the most frequently occurring in Europe and combined, are responsible for nearly 200,000 deaths annually. Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines.’

Sandoz and EirGenix entered into a partnership to develop and commercialize this Herwenda biosimilar in 2019 [3]. As part of the development, EirGenix produced a comprehensive analytical, preclinical, and clinical data regulatory submission package that included evidence derived from an extensive analytical characterization, in addition to results from a phase I pharmacokinetics/pharmacodynamics (PK/PD) study and a confirmatory phase III study in breast cancer patients (EGC002). Both studies met their primary endpoints, confirming that the biosimilar matches the reference biological in terms of PK as well as efficacy, safety, and immunogenicity.

Europe has six trastuzumab biosimilar approved already, they are Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera and Zercepac.  Herwenda will be the seventh trastuzumab biosimilar to be approved in Europe.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-trastuzumab
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. Sandoz and EirGenix make deal for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 3]. Available from:

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