Biosimilar trastuzumab regulatory update

EMA accepted for review an MAA from Samsung Bioepis Co. Ltd. for SB3, a biosimilar of Herceptin trastuzumab from Roche (SIX:ROG; OCTCQX:RHHBY, Basel, Switzerland). Herceptin is approved to treat early and metastatic breast cancer and metastatic gastric cancer. Samsung Bioepis declined to say which indications it is pursuing for the biosimilar. Herceptin is a humanized mAb against epidermal growth factor receptor 2 ( EGFR2; HER2; ErbB2; neu). ...