Samsung Bioepis Data Suggest Clinical Impact From Herceptin Product Quality Drift
Executive Summary
Post hoc data from a long-term safety study of Samsung’s trastuzumab biosimilar and Genentech’s reference product suggest event-free survival rates differ based on a shift in one of Herceptin’s key quality attributes; Genentech said it proactively alerted health authorities when the shift was detected and the evidence does not indicate a clinical impact on patient outcomes.