On September 24, EirGenix (6589) announced that it has received positive feedback from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) during scientific consultations regarding the waiver of Phase III clinical trials for its breast cancer biosimilar candidate, EG1206A (Pertuzumab biosimilar). Consequently, the company has officially terminated the on-going Phase III clinical trial for EG1206A. This decision accelerates the global marketing authorization applications (BLA/MAA) for the product and reduces the originally planned product development expenses. Receiving positive feedback from regulatory agencies reflects EirGenix’s long-standing expertise in biosimilar development and marks a significant milestone in the company’s expansion in the biosimilar market.