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Samsung Bioepis Reports Long-term Ontruzant Findings for HER2-Positive Breast Cancer
The positive findings for the trastuzumab biosimilar Ontruzant in patients with human epidermal growth factor receptor 2 (HER2)–positive early or locally advanced breast cancer were presented at the European Society for Medical Oncology (ESMO) Congress 2021.
Samsung Bioepis reported results of what it called the longest follow-up study of patients with human epidermal growth factor receptor 2–positive early or locally advanced breast cancer treated with a trastuzumab biosimilar. The findings will be formally presented in poster form at the European Society for Medical Oncology (ESMO) Congress 2021.
Investigators said 5-year event-free survival rates in the phase 3 study were 82.8% in the biosimilar (Ontruzant) cohort and 79.7% in the reference trastuzumab (Herceptin) group.
Five-year overall survival rates were 93.1% and 86.7% for the biosimilar (HR 0.62; 95% CI, 0.32-1.22; P = .17) and originator drug cohorts, respectively.
Investigators reported 3 cases of asymptomatic significant left ventricular ejection fraction (LVEF) decrease (Ontruzant, n = 1). Each of these patients recovered with LVEF ≥ 50%. There were no cases of symptomatic congestive heart failure or cardiac death in either cohort.
Events of recurrence, progression and death were reported for 17.2% of patients in the biosimilar group (HR 0.78; 95% CI, 0.48-1.25; P = .30) and 21% in the reference cohort.
Patients in the biosimilar cohort (n = 186) and the reference group (n = 181) received 8 cycles of trastuzumab concurrently with chemotherapy in the neoadjuvant setting. After surgery, they received 10 cycles of trastuzumab over 1 year. Median follow-up duration was 68 months from the point of randomization.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
FTC Releases Second Report on PBMs Meddling in Generic Drug Markets
January 19th 2025The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.
Biosimilars Drive Cost Savings and Achieve 53% Market Share Across Treatment Areas
January 16th 2025Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.
