The breast pathologic complete remission rate was equivalent with biosimilar or reference trastuzumab in the neoadjuvant setting.
The promise of biosimilar therapeutic and supportive agents in oncology offers the possibility of less expensive drugs that are equivalent in efficacy and safety to their reference products. Several biosimilars for trastuzumab are in development, and one (Mylan/Biocon MYL-1401O or trastuzumab-dkst) was recently FDA-approved to treat patients with HER2-positive breast cancer.
To test the efficacy, safety, and immunogenicity of another trastuzumab biosimilar agent (SB3; Samsung Bioepis), investigators conducted an industry-sponsored, randomized, double-blind, phase III study of 800 patients with stage II/III, HER2-positive, primary breast cancer who received neoadjuvant docetaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide plu…
Reviewing Author
DisclosuresConsultant/Advisory BoardLilly; AstraZeneca; Gilead
Grant/Research SupportBreast Cancer Research Foundation
Editorial BoardsClinical Breast Cancer; Oncology; Annals of Surgery; Breast Cancer Research and Treatment
Leadership Positions in Professional SocietiesNational Comprehensive Cancer Network (Chair, Breast Cancer Panel); American Board of Internal Medicine (Medical Oncology Board)
DisclosuresConsultant/Advisory BoardLilly; AstraZeneca; Gilead
Grant/Research SupportBreast Cancer Research Foundation
Editorial BoardsClinical Breast Cancer; Oncology; Annals of Surgery; Breast Cancer Research and Treatment
Leadership Positions in Professional SocietiesNational Comprehensive Cancer Network (Chair, Breast Cancer Panel); American Board of Internal Medicine (Medical Oncology Board)