EirGenix announced today (18 Sep.) that EG12014 (Trastuzumab Biosimilar 150 mg I.V.), a biosimilar drug for breast and gastric cancers, which is licensed to Sandoz AG, has received a positive opinion for the drug from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use. It is anticipated that the product will be made available in the European Union in the fourth quarter of this year.
According to EirGenix, the positive opinion means that the Committee considers the quality, safety and efficacy of the drug to be acceptable. This is an important step in the process of obtaining European market approval for a drug, which is usually obtained after an evaluation following the submission of an application, and this positive opinion will provide the EMA with the final approval to obtain a licence for the drug to be used and sold on the European market.
EG12014 is indicated for the treatment of human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer and metastatic gastric cancer, which is the same indication as the EMA-approved control biologic Herceptin.
In April 2019, EirGenix and Sandoz signed a licensing agreement. Under the contract, it was agreed that EirGenix will be responsible for the development and manufacture of EG12014, while Sandoz will receive worldwide (excluding Taiwan, Mainland China, Japan, South Korea and Russia) sales and the right to commercialise the drug upon approval in the licensed markets.
Breast and stomach cancers are among the most common cancers in Europe, and together they cause nearly 200,000 deaths each year, said EirGenix. Biosimilar medicines have great potential to significantly increase patient access to these important medicines, thereby improving cancer treatment outcomes. Breast and stomach cancers have a significant impact in Europe, with more than 355,000 women diagnosed with breast cancer each year and 92,000 deaths annually, and are the leading cause of cancer deaths in women; stomach cancer is the sixth most common type of cancer of all, leading to 107,000 deaths annually, and is the fourth most common cause of cancer-related deaths in Europe.
EirGenix has analysed that up to 20% of breast cancer cases exhibit HER2 protein overexpression (or amplification of the HER2 gene), resulting in uncontrolled cell growth and division, and that HER2-positive cancers are particularly aggressive and respond well to targeted therapies. Once the product is available in Europe, it will further expand the availability of high-quality therapies for breast and gastric cancers, helping to reduce the burden of these diseases on patients and providing significant ongoing savings to the healthcare system.
EirGenix's breast cancer biosimilar EG12014 "EIRGASUN® vial 150 mg" was also approved by Taiwan’s FDA in May this year. The company applied for health insurance coverage in June, and it is expected that the product will be sold in the fourth quarter after obtaining health insurance coverage.
The company indicated that the continued development of this series of HER2-positive breast cancer product portfolio will be more conducive to the subsequent market expansion and strengthening of competitive advantages, and the future development of the Taiwan and international markets is highly anticipated.
