On the evening of the 24th, EirGenix announced that after consulting with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the company received positive feedback on requesting an exemption for the Phase III clinical trial of its investigational product EG1206A. As a result, EirGenix has decided to terminate the Phase III trial, potentially allowing the product to reach the market earlier.

EG1206A, a pertuzumab biosimilar, is primarily developed for the treatment of HER2-positive early-stage and metastatic breast cancer. Based on the scientific guidance provided by the FDA and EMA, the company decided to streamline the clinical development strategy for EG1206A to accelerate its market entry.

EirGenix emphasized that this adjustment aligns with the latest regulatory guidance for simplified biosimilar development. The comparative analyses and pharmacokinetic data included in the EG1206A development program were designed and executed following the highest scientific and regulatory standards. Whether market approval can be obtained without Phase III data will depend on the completeness and scientific robustness of the submitted dossier.

After careful evaluation, EirGenix concluded that the originally planned Phase III trial for EG1206A is no longer necessary. To enhance development efficiency, the company will focus on compiling the submission materials recommended by regulatory authorities to support the exemption strategy.

Resource: 美國FDA同意豁免 台康生技終止EG1206A三期臨床試驗