EirGenix, Inc.

TAIPEI, Nov. 23, 2023 /PRNewswire/ -- EirGenix Inc. (6589. TT) 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. Website:

TAIPEI, Nov. 22, 2023 /PRNewswire/ -- EirGenix Inc. (6589. TT) 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. Website: SOURCE EirGenix

Phalguni Deswal @Phalguni_GD Herceptin generated Sfr878m ($980m) in global sales in H1 2023, as per Roche’s Q2 financial report. Image Credit: Panaceum Media / Shutterstock. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Sandoz ’s Herceptin (trastuzumab) biosimilar for European marketing approval. Herceptin is a monoclonal antibody that binds to the human epidermal growth factor receptor 2 positive (HER2) receptors to prime them for being targeted by the immune system. It has been approved for the treatment of HER2-positive breast cancer and metastatic gastric cancers. Herceptin generated Sfr878m ($980m) in global sales in H1 2023, as per Roche’s Q2 2023 financial report . Recommended Reports Reports LOA and PTSR Model - tocilizumab biosimilar GlobalData Reports LOA and PTSR Model - denosumab biosimilar GlobalData View all Companies Intelligence Novartis AG Amgen Inc Sandoz Inc EirGenix Inc Allergan Ltd View all The Herceptin biosimilar was developed by EirGenix and is licensed by Sandoz. While EirGenix holds the developmental and manufacturing rights, Sandoz is responsible for the commercialisation of the biosimilar. The CHMP recommendation is based on the Phase I and III studies in patients with breast cancer showing that the biosimilar is non-inferior to the reference biologic. In 2019, the US Food and Drug Administration (FDA) approved Amgen and Allergan ’s Herceptin biosimilar, Kanjinti . The sales for the biosimilar pales in comparison to the Herceptin sales, with Amgen reporting $50m in sales for Q2 2023 for Kanjinti, as per the company’s Q2 financial report . The difference in sales is partly driven by the US reimbursement system which often prioritises the reference biologic over the biosimilars, along with the substantially low cost of biosimilars . With Sandoz expected to break off from Novartis in early October , the Herceptin biosimilar will be added to Sandoz’s biosimilar catalogue. This includes the Tysabri (natalizumab) biosimilar for relapse-remitting multiple sclerosis (RRMS), and the Humira (adalimumab) biosimilar, Hyrimoz , for rheumatoid arthritis and other indications. Earlier this month, Sandoz signed a licensing agreement with Samsung Bioepis to market Stelara biosimilar in Europe and North America .