EirGenix announced on September 7 that its breast cancer and gastric cancer biosimilar Herwenda (EG12014 Trastuzumab Biosimilar 150 mg, intravenous), licensed in April 2019 to European pharmaceutical company Sandoz AG, has received approval from the European Medicines Agency (EMA) for a post-marketing manufacturing site change, as notified by Sandoz on September 5.
The post-marketing change application was submitted to EMA on May 6, 2025, primarily to replace the original formulation manufacturing site. The new facility has completed all process validation and product comparability assessments to ensure bioequivalence.
EirGenix stated that Herwenda was initially approved by the European Commission in November 2023. Following the successful transfer approval, the new facility will produce the 150 mg product, and the 420 mg large-volume formulation will also be launched sequentially after approval. Herwenda is indicated for the treatment of HER2-positive breast cancer and metastatic gastric cancer, matching the approved indications of the reference biologic, Herceptin, under EMA.
Under the April 2019 licensing agreement, Sandoz holds rights to commercialize the product globally, excluding Taiwan, mainland China, Russia, and select Asian countries, once approval is obtained in the licensed territories.
EirGenix highlighted the significant impact of breast and gastric cancers in Europe. Over 355,000 women are diagnosed with breast cancer annually, with 92,000 deaths each year, making it a leading cause of cancer-related death among women. Gastric cancer is the sixth most common cancer type, causing 107,000 deaths annually, ranking fourth among cancer-related mortalities in Europe. In 2024, combined sales of Herceptin and its biosimilars reached US$759 million.
Among breast cancer cases, up to 20% overexpress HER2 protein (or have HER2 gene amplification), leading to uncontrolled cell growth and division. HER2-positive cancers are particularly aggressive but respond well to targeted therapies. The introduction of Herwenda will further expand access to high-quality treatment for breast and gastric cancers in Europe, reducing patient burden and generating substantial healthcare savings.
EirGenix’s EG12014 “EIRGASUN” lyophilized injection 150 mg was approved by Taiwan’s Ministry of Health and Welfare (TFDA) in May 2023 and has since been included in National Health Insurance reimbursement. Currently, 19 hospitals, including medical centers, use EIRGASUN.
EirGenix’s HER2-positive breast cancer product portfolio also includes a biosimilar of the second-generation HER2-targeted antibody Perjeta (Pertuzumab), which has advanced to Phase 3 clinical trials. With successful product launches, the company plans to extend market coverage and strengthen its international competitive position.
Resource: 台康生乳癌生物相似藥上市後變更製劑廠申請 獲歐洲EMA核准
