Sandoz Submits BLA to US FDA for EG12014, a Proposed Biosimilar Trastuzumab to Treat HER2-positive Breast Cancer and Metastatic Gastric Cancers
- The submission is based on analytical, pre-clinical, and clinical data to evaluate proposed biosimilar trastuzumab (150mg, IV) in breast & gastric cancer patients. Trastuzumab biosimilar is being developed by EirGenix
- Sandoz continues to build on generic and biosimilar oncology portfolios to increase patient access and contribute to the sustainability of healthcare systems. Trastuzumab is a mAb that was used to treat HER2-positive breast cancer and metastatic gastric cancers
- In Apr 2019, Sandoz entered into a license agreement with EirGenix where Sandoz get the right to commercialize EG12014 (biosimilar, trastuzumab) globally (Ex- China and Taiwan). EirGenix is responsible for the development and manufacturing of the product
Ref: Globe Newswire | Image: Sandoz
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