The retrospective, real-world study (N = 353) conducted within the Kaiser Permanente network followed the July 2019 launch of the bevacizumab biosimilar Mvasi.
Investigators say they have confirmed the safety and efficacy equivalence of bevacizumab biosimilar Mvasi compared with its reference product (Avastin) in a real-world population of patients with advanced nonsquamous non–small cell lung cancer. The results were presented at Virtual ISPOR 2021.
Investigators studied outcomes in a population of adult patients within the Kaiser Permanente integrated health care network in Northern California and Southern California. Patients were initiated on the biosimilar (n = 58) between July 1, 2019, and March 30, 2020, or on the reference product (n = 295) between July 1, 2015, and June 30, 2018. The primary end point was overall survival (OS) and secondary end points were treatment persistence, serious adverse events (SAEs), and any-cause hospitalization and emergency department visits.
Investigators concluded that OS was not significantly different between the biosimilar and reference cohorts, and there also were no significant differences between cohorts for treatment persistence, SAEs, and hospitalization or emergency department use.
The 6-month OS was 72.1% for the biosimilar cohort and 79.0% for the reference product group (P = .27).
The incidence of hemorrhaging was 3.5% vs 3.7% for patients in the biosimilar vs reference groups, respectively. The respective percentages for thromboembolism were 5.2% vs 3.7%; severe hypertension, 8.6% vs 12.5%; gastrointestinal perforation, 0.0% vs 0.3%; and congenital heart failure, 0.0% vs 1.4%.
In discussion, investigators said study strengths included the capture of real-world outcomes immediately following the launch of Mvasi; comprehensive access to electronic health records on patient history; treatment and outcomes; and use of Cox proportional-hazards modeling, which offers the advantage of simultaneous analysis of the effects of multiple risk factors on survival time.
Limitations of the study included its observational, or retrospective, design, short follow-up, and small sample size.
For related reading on Kaiser Permanente findings on Mvasi in patients with metastatic colorectal cancer, click here.
Reference
Pham C, Ekinci E, Chiu T, et al. Real-world evaluation of biosimilar bevacizumab-awwb versus bevacizumab in patients with advanced non-squamous non-small cell lung cancer in a U.S. integrated healthcare delivery system. Presented at: Virtual ISPOR 2021; May 17-20, 2021. Accessed May 16, 2021. https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-2021
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.