Pharma Focus Asia

Eirgenix's Breast Cancer Biosimilar Secures Marketing Authorization From the European Commission

Thursday, November 23, 2023

EirGenix Inc. (6589.TT) has recently announced that the European Commission (EC) has granted marketing authorization for EG12014, its trastuzumab biosimilar medicine. This biosimilar, with plans for commercialization by Sandoz, is designed for intravenous use at a 150 mg dosage. The EC approval covers the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, aligning with the indications approved for the reference biologic, Herceptin®.

The licensing agreement established in April 2019 between Sandoz AG and EirGenix outlines that EirGenix Inc. will retain responsibility for the development and manufacturing of trastuzumab, while Sandoz will hold the global commercialization rights, excluding specific regions like Taiwan, China, Russia, and certain Asian countries. Breast and gastric cancers pose significant health challenges in Europe, contributing to nearly 200,000 deaths annually. The approval of biosimilars, such as EG12014, holds potential to enhance cancer care by increasing access to essential medicines.

Breast and gastric cancer have a substantial impact in Europe, with over 355,000 women diagnosed with breast cancer annually, making it the leading cause of cancer death among women, claiming 92,000 lives each year. Gastric cancer, the sixth most common cancer type, causes 107,000 deaths annually and ranks fourth in cancer-related deaths in Europe. Up to 20% of breast cancers and 30% of gastric cancers exhibit HER2 protein overexpression or HER2 gene amplification, leading to uncontrolled cell growth. HER2-positive cancers are known for their aggressiveness, responding well to targeted treatment.

The approval of EG12014 in Europe aims to broaden access to a crucial, high-quality treatment for breast and gastric cancers, alleviating the burden on patients and providing significant cost savings for healthcare systems, promoting sustainability.

Additionally, EirGenix's trastuzumab biosimilar has received market approval from Taiwan's Food and Drug Administration (TFDA) in June. Approval of the health insurance pricing application by the National Health Insurance Administration in September paves the way for the formal launch of the product in Taiwan. EirGenix is actively developing a range of HER2-positive breast cancer product combinations, including the second-generation HER2-positive targeted antibody drug Perjeta® (Pertuzumab), advancing into Phase III clinical trials. The successful market introduction of these products is anticipated to drive further market expansion and strengthen the product's international competitive edge.



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