EirGenix Inc., (6589.TT) a Taiwan-based pharmaceutical company, has announced that it has received marketing approval from the European Commission (EC) for its biosimilar version of trastuzumab, known as Roche’s Herceptin. The approval is for the 150mg form of the drug intended for intravenous use, indicated for the treatment of HER2-positive breast and metastatic gastric cancers.
EirGenix’s biosimilar will be commercialized by Swiss pharmaceutical company Sandoz AG, following a licensing agreement signed in April 2019. The agreement granted Sandoz commercial rights for the biosimilar worldwide, excluding Taiwan, China, Russia, and certain Asian countries. EirGenix specializes in the development of HER2-targeted therapies and is also advancing a biosimilar of Perjeta (pertuzumab) in Phase III trials.- Flcube.com