Synthon's biosimilar trastuzumab bioequivalent to Herceptin

Synthon B.V. (Nijmegen, the Netherlands) reported data from a European Phase I trial showing that its biosimilar of trastuzumab was bioequivalent to cancer drug Herceptin trastuzumab. The trial enrolled 118 healthy volunteers. Details were not disclosed. Synthon said it is "aiming at global registration and commercialization" of the biosimilar and plans to start a Phase III trial to treat breast cancer next half. Herceptin is approved for first-line HER2-positive metastatic breast cancer and HER2-positive gastric cancer. The drug is marketed in the U.S. by the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and by Roche elsewhere. ...