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
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.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.
The Next Frontier: Oncology Biosimilars in 2025 and Beyond
January 13th 2025The US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.