A randomized, double-blind, parallel-group, single-dose comparative pharmacokinetic study of DRL_TZ, a candidate biosimilar of trastuzumab, with Herceptin (EU) in healthy adult males.

Background & Objectives: Trastuzumab (TZ) is a recombinant DNA-derived humanized monoclonal antibody approved for human epidermal growth factor receptor 2 positive early breast cancer, metastatic breast and gastric cancers. For the development of TZ biosimilars, establishing pharmacokinetic equivalence is required. The primary objective of this study was to compare the pharmacokinetics (PK) of Dr Reddy's Laboratories TZ (DRL_TZ) with that of EU-approved Reference Medicinal Product (RMP), Herceptin in healthy adult male subjects.