EirGenix Makes Progress With Trastuzumab Biosimilar
Company Plans To Submit Filings To Both FDA and EMA
Taiwan’s EirGenix has made progress with its trastuzumab biosimilar for breast cancer, EG12014, announcing positive Phase III clinical results for the Herceptin equivalent.
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Sandoz and EirGenix have followed their US filing for a biosimilar rival to Herceptin with a European filing for the EG12014 trastuzumab candidate.
Sandoz has filed the proposed trastuzumab biosimilar developed by partner EirGenix with the US FDA. If approved, the product will have to compete in an already busy market for Herceptin biosimilars.
Merck & Co has launched Ontruzant, the trastuzumab biosimilar developed and manufactured by Samsung Bioepis, in the US following a staggered approval process and earlier intellectual-property hurdles. The list price discount offered by the firm puts it in the middle of the pack among the four other biosimilar players currently on the market.