EirGenix recently announced that its investigational product EG1206A, a pertuzumab biosimilar, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with a Phase III clinical trial.

EG1206A is EirGenix’s second-generation breast cancer biosimilar. The company’s first-generation biosimilar, trastuzumab (EG12014), has already obtained marketing approvals in both the European Union and Taiwan. However, for the U.S. market, the FDA issued a Complete Response Letter (CRL) in December last year, meaning the product’s entry into the U.S. market will be delayed.

EirGenix stated that the reference drug for EG1206A is Perjeta (pertuzumab), which recorded global sales of CHF 3.77 billion (approximately USD 4.48 billion) in 2023, according to Roche’s annual report. Compared to its first-generation biosimilar EG12014, EG1206A is primarily indicated for the treatment of HER2-positive early-stage and metastatic breast cancer, with a significantly larger market potential.

Resource: 台康第二代乳癌生物相似藥EG1206A 獲美核准三期臨床