EirGenix announced on March 17 that its trastuzumab biosimilar, Herwenda (EG12014, 150mg IV), has officially commenced sales in Slovakia via its global partner, Sandoz AG. This marks the first European market entry for the product, signaling the full-scale activation of EirGenix's European commercial strategy.

• Regulatory & Manufacturing Readiness: Approved by the EC in late 2023, Herwenda secured EMA manufacturing site change approval in September 2025. EirGenix’s Zhubei facility has passed EU-GMP inspections, ensuring a stable supply of the 150mg dosage, with a 420mg high-capacity version currently in the pipeline.
• Market Significance: Trastuzumab targets HER2-positive breast and gastric cancers—diseases that claim nearly 200,000 lives annually in Europe. With Roche’s Herceptin generating approximately CHF 1.03 billion in 2025 and the biosimilar market reaching US$690 million, Herwenda aims to significantly lower healthcare expenditures while increasing patient access.
• Product Synergy: EirGenix and Sandoz expanded their partnership in November 2025 to include EG1206A (pertuzumab biosimilar). Once launched, the combination of EG12014 and EG1206A will offer a comprehensive HER2-targeting portfolio, aligning with the current international standard of care.

Resource: 台康生技乳癌生物相似藥EG12014歐洲首站開賣，斯洛伐克率先上市