A phase I dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers.

Wisman LA, De Cock EP, Reijers JA, Kamerling IM, Van Os SH, de Kam ML, Burggraaf J, Voortman G

Trastuzumab (Herceptin(®)) is a humanized monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER2) and is used in the treatment of HER2-overexpressing breast and gastric cancer. FTMB is being developed as a biosimilar of trastuzumab.