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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.
13 Strategies to Avoid the Nocebo Effect During Biosimilar Switching
December 18th 2024A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.
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.
Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar vs Originator
December 11th 2024Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
