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Real-World Evidence for Comparative Outcomes between Innovator and Biosimilar Bevacizumab in Advanced Colorectal Cancers.
South Asian J Cancer
October 2024
Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Dr. E Borges Road, Parel, Mumbai, Maharashtra, India.
Purpose: Generic versions of bevacizumab are commonly used in India in patients with advanced/metastatic colorectal cancers (mCRCs), but there is limited real-world evidence (RWE) about their efficacy in comparison to the innovator bevacizumab.
Methods: Patients diagnosed with mCRC between January 2017 and January 2022 and receiving a combination of chemotherapy and bevacizumab were retrospectively analyzed for demographic variables and survivals. The primary endpoint of the study was the estimation and comparison of median progression-free survival (mPFS) between patients receiving innovator versus generic bevacizumab as first-line therapy (CT1) by the Kaplan-Meier method.
Physicochemical stability of bevacizumab biosimilar CT-P16 (Vegzelma) concentrate for solution stored in original vials after first opening.
Eur J Hosp Pharm
March 2025
Pharmacy, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Rheinland-Pfalz, Germany.
Objective: After patent expiry of the bevacizumab originator product, several biosimilars were approved by the European Medicines Agency. In centralised preparation units, product-specific in-use stability data must be considered. Based on the available data, stability information was missing for the concentrate for solution of the bevacizumab biosimilar CT-P16 (Vegzelma, Celltrion) after first opening and prolonged storage.
View Article and Find Full Text PDFSafety of an Intravitreal Bevacizumab Biosimilar (MVASI).
Clin Exp Ophthalmol
March 2025
Department of Ophthalmology, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.
Background: Intravitreal bevacizumab has been used off-label to treat multiple ocular conditions for almost two decades. Reference bevacizumab, Avastin, was discontinued in Australia in 2021. A bevacizumab biosimilar, MVASI, was approved by the Therapeutic Goods Administration for the treatment of metastatic cancer in 2020.
View Article and Find Full Text PDFCost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare.
J Med Econ
December 2025
OPEN Health, Bethesda, MD, USA.
Background: Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.
Methods: We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd.
Optimizing biosimilar development: current approaches to demonstrating pharmacokinetic and analytical similarity and a proposal for a single reference approach.
Expert Opin Biol Ther
March 2025
Parexel Consulting (PC), Regulatory Strategy, Regulatory Consulting, Parexel International, Dublin, Ireland.
Objectives: Many biosimilars have been approved in both the United States of America (U.S.A.
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