EirGenix Inc. announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin®.
Sandoz AG and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix Inc. will remain responsible for the development and manufacturing of trastuzumab while Sandoz will hold the rights to commercialize the medicine upon approval in the global market (excluding Taiwan, China, Russia, and some Asian countries). 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.
The impact of both breast and gastric cancer in Europe is significant. Each year, over 355,000 women are diagnosed with breast cancer, and with 92,000 deaths per year, it is the number one cause of cancer death among women. Gastric cancer is the sixth most common of all cancer types and with 107,000 deaths annually it is the fourth most common cause of cancer-related death in Europe. In up to 20% of breast cancers and up to 30% of gastric cancers diagnosed, a HER2 protein overexpression (or HER2 gene amplification) is detected resulting in an uncontrollable growth and division of cells. HER2 cancers are particularly aggressive cancer types that respond well to targeted treatment. The authorisation of EG12014 in Europe expands access to a vital, high-quality treatment for breast and gastric cancers helping to ease the burden of these diseases on patients and delivering important savings for healthcare systems to ensure sustainability.
EirGenix's trastuzumab biosimilar drug (EG12014) (150 mg lyophilized powder for injection) also received market approval by TFDA in June. The application of the health insurance pricing was approved by the National Health Insurance Administration under the Ministry of Health and Welfare in mid-September, paving the way for the formal launch of the product in Taiwan. EirGenix develops a series of HER2-positive breast cancer product combinations, including the second-generation HER2-positive targeted antibody drug Perjeta® (Pertuzumab), which are continuously advancing into the Phase III clinical trial. With the successful market introduction of the products, further market expansion and strengthening of the product's international competitive advantage will be realized.
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