- |||||||||| 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.
- |||||||||| Avastin (bevacizumab) / Roche, Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Journal, HEOR: Comparison of Efficacy, Safety, and Economic Outcomes Between Biosimilar ABP 215 and Originator Bevacizumab in Japanese Patients With Colorectal Cancer. (Pubmed Central) - Nov 25, 2024 Economic outcomes indicated a potential savings of approximately 800,000 Japanese yen per patient with biosimilar ABP 215 use. Conclusions Although this is a single-center, retrospective, observational study with limitations in terms of the number of cases and background factors, the use of the bevacizumab biosimilar ABP 215 product is recommended in Japan from the perspective of reducing medical costs, given the findings of no differences in efficacy and safety.
- |||||||||| Vectibix (panitumumab) / Amgen, Lumakras (sotorasib) / Amgen, Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Trial completion date, Trial primary completion date: CodeBreaK 301: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-na (clinicaltrials.gov) - Oct 18, 2024 P3, N=450, Recruiting, Conclusions Although this is a single-center, retrospective, observational study with limitations in terms of the number of cases and background factors, the use of the bevacizumab biosimilar ABP 215 product is recommended in Japan from the perspective of reducing medical costs, given the findings of no differences in efficacy and safety. Trial completion date: Jan 2031 --> Apr 2031 | Trial primary completion date: Jun 2027 --> Sep 2027
- |||||||||| Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Treatment Outcomes in Patients who Received Bevacizumab Therapy for Radiation Induced Brain Necrosis (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1494; The secondary outcomes were to assess the safety of bevacizumab for the treatment of RBN in adults, evaluate whether clinical benefit varied based on bevacizumab dosing strategy, and determine if there are differences in outcomes with bevacizumab and biosimilar product, bevacizumab-awwb...Bevacizumab possessed a manageable safety profile and was well-tolerated. Additionally, our study demonstrated that clinical benefits were similar across dosing strategies including dosage, frequency, and biological product.
- |||||||||| Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Retrospective data, Journal, Real-world evidence, Real-world: Real-World Use of Off-Label MVASI in the Treatment of Patients With Neovascular AMD and DME. (Pubmed Central) - Jul 23, 2024 In our cohort of patients with n-AMD and DME in the maintenance phase, bevacizumab-awwb seems to represent a viable and cost-effective intravitreal therapy with comparable efficacy and safety to the originator. This study provides a preliminary assessment of the efficacy and safety of intravitreal bevacizumab-awwb, which is widely used off-label in retinal vascular diseases.
- |||||||||| Tecentriq (atezolizumab) / Roche, Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Liver cancer in ovo models for preclinical testing (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_1520; This study provides a preliminary assessment of the efficacy and safety of intravitreal bevacizumab-awwb, which is widely used off-label in retinal vascular diseases. Treatments with atezolizumab (anti-PD-L1, TECENTRIQ
- |||||||||| Entresto (sacubitril/valsartan) / Novartis, ROVI Pharmaceuticals Laboratories, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca, Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
ONE BATTLE AFTER ANOTHER: BEVACIZUMAB CARDIOMYOPATHY AFTER HIGH-GRADE ENDOMETRIAL CARCINOMA (Hall B4-5) - Jan 26, 2024 - Abstract #ACC2024ACC_4920; Around 2-4% of bevacizumab-treated patients develop cardiomyopathy and heart failure. Bevacizumab biosimilar cardiotoxicity data are limited.
- |||||||||| Lumakras (sotorasib) / Amgen, Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Combination therapy, Metastases: A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis (clinicaltrials.gov) - Oct 18, 2023 P1/2, N=0, Withdrawn, Bevacizumab biosimilar cardiotoxicity data are limited. N=43 --> 0 | Trial completion date: Jun 2028 --> Jan 2023 | Recruiting --> Withdrawn | Trial primary completion date: Dec 2026 --> Jan 2023
- |||||||||| Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Real-world safety and effectiveness of MVASI in metastatic colorectal cancer patients in Canada. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4921; Compared with clinical trials of MVASI and reference bevacizumab, the EOI profile and the OS data are similar, but lower rates of individual EOIs are observed in this real-world setting. The shorter PFS observed in wave 1 may be due to higher rates of comorbidities at baseline and longer time from mCRC diagnosis to index.
- |||||||||| Kanjinti (trastuzumab-anns) / Amgen, Daiichi Sankyo, AbbVie, Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Journal, HEOR: Comparative cost savings of biosimilar and dose rounding utilization in oncology care. (Pubmed Central) - Oct 20, 2022 The shorter PFS observed in wave 1 may be due to higher rates of comorbidities at baseline and longer time from mCRC diagnosis to index. Combining dose rounding with biosimilar substitution for trastuzumab and bevacizumab resulted in significant cost savings per dose and should be implemented by healthcare systems.
- |||||||||| Beianting (bevacizumab biosimilar) / Betta Pharma, Chinese PLA General Hospital, Beijing Mabworks Biotech, Avastin (bevacizumab) / Roche, Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Retrospective data, Journal: Retrospective Indication-Matched Cohort Study of Reference Product and Biosimilar: Bevacizumab Versus Bevacizumab-Awwb. (Pubmed Central) - Jul 30, 2022 Median drug cost per dose and per milligram for bevacizumab-awwb was less than bevacizumab, representing a 15.8% and 12.1% discount, respectively. Utilization and safety outcomes were similar for this indication-matched cohort of 68 patients receiving bevacizumab or bevacizumab-awwb across a wide range of disease states.
- |||||||||| Lumakras (sotorasib) / Amgen, Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Enrollment open, Trial initiation date, Combination therapy, Metastases: A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis (clinicaltrials.gov) - Jul 1, 2022 P1/2, N=43, Recruiting, Utilization and safety outcomes were similar for this indication-matched cohort of 68 patients receiving bevacizumab or bevacizumab-awwb across a wide range of disease states. Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Jun 2022
- |||||||||| 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 It is anticipated that upcoming additional observations from this study will refine the real-world profile of this patient population. No abstract available
- |||||||||| Avastin (bevacizumab) / Roche, Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Real-world outcomes among patients with metastatic colorectal cancer treated first line with bevacizumab-awwb. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1498; No abstract available Biosimilar bevacizumab-awwb appeared to be well tolerated, with observed EOIs being manageable, and 12-month OS probability of > 70% for treating patients with mCRC in the real-world setting.a> 1 EOI can be reported for a patient and each EOI can result in > 1 management.
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Clinical, Journal, Real-world evidence: Real-world use of bevacizumab-awwb, a bevacizumab biosimilar, in US patients with metastatic colorectal cancer. (Pubmed Central) - Mar 8, 2022 Among RP-experienced patients, 83% were transitioned from RP to bevacizumab-awwb in the same line without disease progression; of those, the majority (83%) were transitioned within 28 days. Early evidence from US oncology practices suggests clinical adoption of bevacizumab-awwb in treating mCRC patients.
- |||||||||| Kanjinti (trastuzumab biosimilar) / Amgen, Daiichi Sankyo, AbbVie, Herceptin (trastuzumab) / Roche, Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Clinical, Journal: Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US. (Pubmed Central) - Jan 11, 2022 Initial evidence from the first 12 months following market entry suggests rapid clinical adoption of bevacizumab-awwb and trastuzumab-anns across all approved tumor types. Usage of these two biosimilars was observed in both RP-naïve patients and patients who were previously treated with RP, with no distinctive differences in patient characteristics between the two groups.A video abstract is available for this article as part of the Kanjintionline supplemental material.
- |||||||||| Lumakras (sotorasib) / Amgen, Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
New P1/2 trial, Combination therapy, Metastases: A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis (clinicaltrials.gov) - Jan 6, 2022 P1/2, N=43, Not yet recruiting,
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Clinical, Review, Journal: Clinical and Regulatory Considerations for the Use of Bevacizumab Biosimilars in Metastatic Colorectal Cancer. (Pubmed Central) - Dec 16, 2021 When equivalent safety and efficacy have been demonstrated in one setting, the totality of evidence, together with scientific justification that there are no anticipated differences between the RP and proposed biosimilar in mechanism of action, pharmacokinetics, immunogenicity or toxicity, allows extrapolation into indications where clinical studies were not performed with the proposed biosimilar. Here, we review the approval process for biosimilars, focusing on the licensing of bevacizumab biosimilars and their extrapolation to metastatic colorectal cancer.
- |||||||||| Avastin (bevacizumab) / Roche
[VIRTUAL] Safety of Rapid Infusion Bevacizumab Biosimilar () - Oct 5, 2021 - Abstract #COSA2021COSA_226; Conclusions Our report demonstrates the safety of administering biosimilar bevacizumab at a rapid infusion rate when switching from the originator biosimilar, across different dosing levels and in different tumour types. These findings will allow us to continue administering bevacizumab in the home without compromising the patient experience.
- |||||||||| Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie
Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date, Metastases: A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - May 20, 2021 P3, N=0, Withdrawn, 39 cases were attributable to bevacizumab-awwb (84.8%) and 7 to bevacizumab-bvzr (15.2%). N=170 --> 0 | Trial completion date: May 2023 --> Nov 2022 | Initiation date: Jan 2022 --> May 2021 | Not yet recruiting --> Withdrawn | Trial primary completion date: May 2023 --> Nov 2022
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Journal: Determining Optical Mapping Errors by Simulations. (Pubmed Central) - May 14, 2021 Source codes supporting the presented results are available at: https://github.com/mvasinek/olgen-om-error-prediction...website, at: https://bionanogenomics.com/library/datasets/. Supplementary data are available at Bioinformatics online.
- |||||||||| Zyclara (imiquimod) / Mochida, Mylan, Bausch Health, Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
[VIRTUAL] PD-1 BLOCKADE ENHANCES THERAPEUTIC BENEFITS OF VACCINE IN A CHRONIC SIV/MACAQUE MODEL () - Mar 18, 2021 - Abstract #CROI2021CROI_286; Two groups were subsequently immunized with two DNA-SIV239/MVASIV239 prime/boost vaccines...Both vaccinated groups also received the ectopic application of imiquimod (a TLR7 agonist) as a potential immune adjuvant/latency reversal agent... Our findings reveal that PD-1 blockade enhances the therapeutic benefits of vaccination by improving and sustaining the function and localization of vaccine-induced CD8 T cells to BCF and decreasing viral reservoirs.
- |||||||||| Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, AbbVie
Journal: Off-label infusion of biosimilar bevacizumab: A provincial experience. (Pubmed Central) - Jan 8, 2021 Our province adopted the accelerated infusion time at time of biosimilar bevacizumab (Mvasi) adoption. Our experience with the accelerated infusion time was well tolerated in the first five months of biosimilar bevacizumab adoption across different tumor types.
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