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FINWIRES

EirGenix Partner Secures EMA Nod for Breast Cancer Biosimilar Vial

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EirGenix (TPE:6589) said the European Medicines Agency (EMA) approved a variation application submitted by its licensing partner Sandoz AG to add a 420 mg vial presentation for its trastuzumab biosimilar HERWENDA (EG12014).

The biosimilar is indicated for the treatment of HER2-positive early and metastatic breast cancer, as well as metastatic gastric cancer, according to a Sunday Taiwan Exchange filing.

EirGenix said the approval follows the launch of the 150 mg presentation in Slovakia and supports preparations for a broader commercial rollout across the European Union.

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