Open AccessA 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
Author(s) -
Jason D. Lickliter,
Rakesh Naranbhai Dadhania,
Ravi Trivedi,
Santosh Kumar,
Pramod Kumar Reddy
Publication year - 2021
Publication title -
indian journal of medical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.578
H-Index - 87
ISSN - 0971-5916
DOI - 10.4103/ijmr.ijmr_1119_18
Subject(s) - pharmacokinetics , trastuzumab , cmax , biosimilar , medicine , confidence interval , adverse effect , pharmacology , breast cancer , gastroenterology , cancer
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.