(EIRGASUN®/HERWENDA®) Trastuzumab Biosimilar
EIRGASUN was officially approved from the Taiwan Food and Drug Administration for EG12014 (Trastuzumab Biosimilar) "EIRGASUN®". This drug approval is for a 150 mg cryo-crystal injection formulation, which approved to use for the indications covered by the control drug Herceptin®, including the treatment of early-stage HER2-positive breast cancer, metastatic breast cancer, and gastric cancer.
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 AG is the Marketing Authorisation Holder, and the product is commercialized under a license from EirGenix.
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.