EMA accepts Samsung Bioepis' Herceptin biosimilar application for review

4 October 2016
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South Korean drug developer Samsung Bioepis is closer to bringing another biosimilar to the European market – this time referencing the breast and gastric cancer drug Herceptin (trastuzumab).

The company, a joint venture between Korean conglomerate Samsung and US biotech Biogen (Nasdaq: BIIB), has had its Marketing Authorization Application (MAA) accepted by the European Medicines Agency (EMA) for the SB3 biosimilar candidate referencing the branded biologic sold by Genentech, a subsidiary of Swiss drug giant, Roche (VTX: ROG).

"If approved, we hope our affordable, high-quality medicine will help realize the promise of biosimilars for breast cancer patients across Europe"

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