EMA reviewing Samsung Bioepis biosimilar of Herceptin

Samsung Bioepis said EMA accepted for review an MAA for SB3, a biosimilar of Herceptin trastuzumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).

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. ...