Bevacirel (bevacizumab biosimilar) / Reliance Life Sci, Lupin - LARVOL DELTA

An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies. (PubMed, BioDrugs) - "The Python-based tool offers a high-throughput and a reliable platform for glycosimilarity assessment, outperforming traditional analysis. Minor variations in glycosylation patterns were observed among the biosimilars, suggesting a modest glycosimilarity variation (GI range between 80 and 100%). However, the limited number of innovator batches analyzed constrained the establishment of definitive tolerance limits. Future studies should focus on analyzing larger datasets to improve accuracy and define precise tolerance limits, enhancing the tool's reliability and its potential to accelerate biosimilar development."

Journal

Efficacy, safety, and cost-effectiveness of biosimilars of bevacizumab in näive patients with diabetic macular edema. (PubMed, Indian J Pharmacol) - "The biosimilars of bevacizumab are safe and efficacious in treating DME in a cost-effective manner."

Clinical • Cost effectiveness • HEOR • Journal • Diabetic Macular Edema • Ophthalmology

Assessment of structural and functional similarity of biosimilar products: Bevacizumab as a case study. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "A comprehensive analytical and functional biosimilarity assessment has been performed to examine and compare innovator product of bevacizumab (Avastin-innovator product, Roche Products (India) Pvt Ltd) and six biosimilars that are being marketed in India (Abevmy from Mylan Pharmaceuticals Pvt Ltd, Bevazza from Lupin Ltd, Bryxta from Zydus Cadila, Krabeva from Biocon, Ivzumab from RPG Life Sciences Ltd, and Advamab from Alkem Laboratories Ltd)...The analysis of the analytical, functional and chemometric results revealed significant levels of similarity, with biosimilar4 being the sole exception. Despite being within product specifications, Biosimilar4 displayed significant deviations with respect to critical quality attributes, including a lower proportion of monomer content, a larger percentage of basic charge variant species, and a lower proportion of aglycosylated glycoform."

Journal • Breast Cancer • Oncology • Solid Tumor

Bevacizumab plus erlotinib maintenance versus observation in advanced biliary tract cancers: Results from the phase II component of a prospective integrated phase II-phase III parallel design superiority clinical trial (BEER-BTC study) (ESMO 2023) - "Eligible patients with advanced BTC who had responsive or stable disease status post 6 months of gemcitabine – based chemotherapy were randomly assigned (1:1) to either observation arm (O) or intervention arm (BEER), which was a combination of Bevacizumab 5 mg/m2 IV every 21 days plus erlotinib 100 mg once daily,...Conclusions The combination of bevacizumab and erlotinib improves progression free survival in patients with chemotherapy responsive advanced BTC in this phase 2 clinical trial. The ongoing phase III component of the study will evaluate whether the significant benefit in PFS translates to improvement in overall survival."

Clinical • Head-to-Head • Metastases • P2 data • P3 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Safety and efficacy of bevacizumab biosimilar in recurrent/ progressive glioblastoma. (PubMed, Ecancermedicalscience) - "These patients were either offered Bevacizumab innovator (Avastin, Roche) or biosimilar (BevaciRel: Reliance Life sciences or Bryxta: Zydus Oncosciences) depending upon the financial status and affordability of the patients...The adverse events and safety profiles were comparable between the two groups. In the recurrent/progressive glioblastoma patients, both innovator and biosimilar bevacizumab seem to have similar safety and clinical efficacy."

Clinical • Journal • Glioblastoma • Glioma • Oncology • Solid Tumor

[VIRTUAL] Safety and efficacy of bevacizumab biosimilar in glioma. (ASCO 2020) - "These patients were either offered Avastin or Bevacizumab biosimilar (BevaciRel: Reliance Life sciences or Bryta: Zydus Oncosciences) depending upon the financial affordability... In the brain tumor patients, both innovator and bio-similar bevacizumab seem to have similar clinical efficacy. Research Funding: None"

Clinical • Brain Cancer • Glioma • Oncology • Solid Tumor