Zybev (bevacizumab biosimilar) / Zydus Lifesci, Ligand - 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

Zydus secures COFEPRIS approval for Bhava Biosimilar in Mexico (Indiainfoline (IIFL)) - "On July 22, 2024, Zydus Lifesciences announced that it has received approval from Mexico’s regulatory authority, COFEPRIS, to market Bhava, a Bevacizumab biosimilar. Bhava will be available in two strengths: 100 mg/4 ml and 400 mg/16 ml. It is designed to treat various cancers, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, metastatic breast cancer, glioblastoma, advanced or metastatic renal cell carcinoma, and ovarian cancer."

Approval • Breast Cancer • Colorectal Cancer • Glioblastoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma

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

Efficacy and safety analysis of intravitreal bio-similar products of bevacizumab in patients with macular edema because of retinal diseases. (PubMed, Indian J Ophthalmol) - "The purpose of this study was to evaluate retrospectively the efficacy and safety profile of intravitreal injection of bevacizumab bio-similar product Zybev(Z) for macular edema because of retinal diseases. During the follow-up period after injection, no patient had inflammation, endophthalmitis, an increase in intra-ocular pressure, or systemic side effects. This short-term retrospective analysis provides evidence regarding the efficacy and safety of intravitreal injection of bio-similar products of bevacizumab for the treatment of macular edema because of retinal diseases."

Journal • Inflammation • Macular Edema • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

use of biosimiliar ( ranibuzumab/ bevacizumab-razumab/zybev) for macular pathology (AIOC 2020) - No abstract available