(EIRGASUN®/HERWENDA®) Trastuzumab Biosimilar
EIRGASUN® (EG12014) is a trastuzumab biosimilar to the reference medicine Herceptin®, developed by EirGenix and approved by the Taiwan Food and Drug Administration (TFDA). The approved 150 mg lyophilized powder for injection is indicated for HER2-positive early and metastatic breast cancer and HER2-positive metastatic gastric cancer, in accordance with locally approved prescribing information.
Herwenda® (a trastuzumab biosimilar) received marketing authorization in the European Union in November 2023 and commenced commercial sales in the Slovak Republic on March 17, 2026, making Slovakia the product’s first commercial market in Europe. Sandoz GmbH is the EU Marketing Authorisation Holder, while Sandoz AG is EirGenix's licensing partner for the product.
Herwenda® provides patients with a high-quality, reliable, and cost-effective trastuzumab biosimilar treatment option that addresses clinical needs.
Key product features include:
- HERWENDA® is well tolerated, with a safety profile comparable to the reference trastuzumab.
- HERWENDA® demonstrates an immunogenicity profile comparable to the reference trastuzumab.
- HERWENDA® demonstrates a pharmacokinetic profile comparable to the reference trastuzumab in clinical studies.
（Disclaimer）
Herwenda® (trastuzumab) is a medicinal product for which Sandoz is the Marketing Authorisation Holder. The package image is shown for identification and informational purposes only. Product presentation may vary by country and may change over time. Please refer to the locally approved prescribing information and package leaflet for complete product information. Display of the package image does not constitute medical advice or a recommendation for treatment. Healthcare professionals should consult the current approved product information before prescribing or administering the product.