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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.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.
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.
Unlocking Biosimilar Potential in Specialty Pharmacies With Legislative Support, Formulary Changes
April 24th 2025Sophia Humphreys, PharmD, MHA, BCBBS, emphasized that legislative support and formulary changes are crucial for overcoming unique challenges in specialty pharmacies and driving the growth of biosimilar adoption, which has significant cost saving potential in the next decade.
Decade of Biosimilars Yields $36 Billion in Savings and Strengthens Supply Chain
April 24th 2025Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted that biosimilars saved $36 billion over the last decade by improving patient access and the supply chain, but continued education and a robust pipeline are crucial for future growth.
