Zirabev (bevacizumab-bvzr) / Pfizer 
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 4 Diseases   1 Trial   1 Trial   129 News 


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  • ||||||||||  Rituxan (rituximab) / Roche
    Journal, Adverse events:  Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database. (Pubmed Central) -  Jan 3, 2025   
    Significant AE reporting signals were identified: 1) death for biological rituximab, pruritus for biosimilar rituximab-pvvr, and infusion related reaction for biological rituximab and biosimilar rituximab-pvvr (significantly higher ROR for rituximab-pvvr than biological rituximab, p?<?.0001); 2) death for biological bevacizumab and biosimilar bevacizumab-bvzr (significantly higher ROR for bevacizumab-bvzr than biological bevacizumab, p?<?.0001), hypertension, platelet count decreased (PCD), and proteinuria for biological bevacizumab and biosimilar bevacizumab-awwb (significantly higher ROR of PCD for bevacizumab-awwb than originator bevacizumab, p?=?.001); and 3) rash for biosimilar trastuzumab-anns. Findings call for large, longitudinal studies to examine causality of certain AEs with rituximab-pvvr and bevacizumab biosimilars.
  • ||||||||||  Zirabev (bevacizumab-bvzr) / Pfizer, Avastin (bevacizumab) / Roche
    Cost-Efficiency Modeling of Conversion to Biosimilar Bevacizumab-bvzr in Metastatic Non-Small Cell Lung Cancer in Medicare (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1453;    
    Conclusions : In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mNSCLC, we find that bevacizumab-bvzr + paclitaxel + carboplatin can result in substantial cost savings relative to originator-based first line treatment of patients with non-squamous mNSCLC in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.
  • ||||||||||  Zirabev (bevacizumab-bvzr) / Pfizer
    Trial completion date, Trial primary completion date:  A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer (clinicaltrials.gov) -  Aug 30, 2023   
    P=N/A,  N=400, Not yet recruiting, 
    Bevacizumab biosimilars demonstrated real-world cost-savings while providing similar survival benefit as originator bevacizumab, confirming the initial expectations of their implementation. Trial completion date: Aug 2025 --> May 2025 | Trial primary completion date: Aug 2024 --> May 2025
  • ||||||||||  Zirabev (bevacizumab-bvzr) / Pfizer, Avastin (bevacizumab) / Roche, Yervoy (ipilimumab) / Ono Pharma, BMS
    Journal:  Interventions to reduce waste and improve billing compliance with medications in single-dose vials. (Pubmed Central) -  Nov 3, 2022   
    No negative tolerance signal has been observed. Using a grouper and implementing dose rounding, the institution reduced drug waste, saved money, and reduced the incidence of claims noncompliant with Medicare Part B billing requirements.
  • ||||||||||  Zirabev (bevacizumab biosimilar) / Pfizer
    Journal:  Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials. (Pubmed Central) -  Jul 23, 2022   
    As there are limited data available on bevacizumab biosimilar use in real world settings, future research should be conducted to see if utilization for biosimilar products continues to rise as well as safety over time. Consequently, residual PF-06439535 solution (25 mg/mL) in opened vials may be regarded as stable when stored light-protected over a period of 8 days in the refrigerator (2-8°C) or at 25°C.
  • ||||||||||  Eylea (aflibercept intravitreal) / Bayer, Regeneron, Susvimo (ranibizumab port delivery system) / Roche, Lucentis (ranibizumab) / Roche, Novartis
    Journal:  A ranibizumab ocular implant (Susvimo) for age-related macular degeneration. (Pubmed Central) -  May 3, 2022   
    Consequently, residual PF-06439535 solution (25 mg/mL) in opened vials may be regarded as stable when stored light-protected over a period of 8 days in the refrigerator (2-8°C) or at 25°C. No abstract available
  • ||||||||||  Zirabev (bevacizumab biosimilar) / Pfizer
    Retrospective data, Journal, Real-world evidence:  Real-world usage of bevacizumab-bvzr biosimilar in US oncology practice. (Pubmed Central) -  Apr 21, 2022   
    Utilization was observed in extrapolated indications. Findings suggest that both switching between reference product and bevacizumab biosimilars and using bevacizumab-bvzr as part of chemotherapy combination regimens have been adopted in US oncology practice.
  • ||||||||||  Zirabev (bevacizumab biosimilar) / Pfizer
    Journal:  Physicochemical stability of PF-06439535 (bevacizumab-bvzr; Zirabev), a bevacizumab biosimilar, under extended in-use conditions. (Pubmed Central) -  Mar 23, 2022   
    Findings suggest that both switching between reference product and bevacizumab biosimilars and using bevacizumab-bvzr as part of chemotherapy combination regimens have been adopted in US oncology practice. The stability and biological activity of PF-06439535 was maintained after dilution and storage for up to 6 weeks at 2-8°C, demonstrating the integrity of diluted PF-06439535 under extended in-use conditions.
  • ||||||||||  Avastin (bevacizumab) / Roche, Herceptin (trastuzumab) / Roche, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Real-World Utilization Patterns of Oncology Biosimilar Monoclonal Antibodies and Their Corresponding Reference Products (In-person & Virtual) -  Mar 8, 2022 - Abstract #ISPOR2022ISPOR_1644;    
    The objective of this study was to describe real-world treatment pattens of rituximab-pvvr, trastuzumab-qyyp, and bevacizumab-bvzr and their associated reference biologics...Both originator and biosimilar products were used along with specific drug regimens for NHL (CHOP, CVP, DHAP), BC (docetaxel+carboplatin+pertuzumab, docetaxel+carboplatin, pertuzumab+paclitaxel/docetaxel), and CRC (FOLFOX, CAPOX, FOLFIRI, FOLFOXIRI). Biosimilar-mAb products are being utilized in a manner similar to their reference biologic-mAbs in real-world clinical settings.
  • ||||||||||  Zirabev (bevacizumab-bvzr) / Pfizer
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Metastases:  A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC (clinicaltrials.gov) -  Jun 4, 2021   
    P3,  N=8, Completed, 
    Completed --> Terminated; The study was terminated as part of the decision by Pfizer to halt its biosimilars programs in China. Recruiting --> Completed | N=216 --> 8 | Trial completion date: Oct 2023 --> May 2021 | Trial primary completion date: Mar 2022 --> May 2021
  • ||||||||||  Zirabev (bevacizumab biosimilar) / Pfizer, Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
    [VIRTUAL] Biosimilar usage in practices within the ASCO PracticeNET learning network. () -  Sep 4, 2020 - Abstract #ASCOQC2020ASCO_QC_148;    
    Our analysis identified an approximate 2-year lag from product approval to initial utilization followed by a steady increase in the use of biosimilar products, along with a wide range of use among practices. Research Funding: None.
  • ||||||||||  Zirabev (bevacizumab biosimilar) / Pfizer, Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
    Journal:  Bevacizumab biosimilars: scientific justification for extrapolation of indications. (Pubmed Central) -  Apr 3, 2019   
    Extrapolation of indications for a biosimilar to other eligible indications held by the originator, in the absence of direct clinical comparison, frequently forms part of the regulatory judgment. Herein, we consider the evidence required to demonstrate biosimilarity for bevacizumab biosimilars, with particular focus on the rationale for extrapolation across oncologic indications.