EMA approves first Herceptin biosimilar

Samsung Bioepis Co. Ltd. said the European Commission approved Ontruzant (SB3), a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit. Ontruzant is the first trastuzumab biosimilar approved in the EU.

The biosimilar is approved to treat HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic gastric cancer -- the same approved indications as Herceptin...