Vivitra (trastuzumab biosimilar) / Novavax, Ligand, Zydus Lifesci - LARVOL DELTA

Removal of Excipients from Drug Product may Impact Antibody Characterization of Monoclonal Antibodies. (PubMed, AAPS J) - "In this study, we elucidate this interference using Trastuzumab (Tmab) reference product, Herclon, and its commercially available biosimilars, Herzuma and Vivitra, as an example. The intrinsic fluorescence spectra displayed major wavelength maxima shifts of up to 6 nm. In view of these results, it is recommended that biosimilar manufacturers consider the impact of differences in formulation in the samples that are being compared as well as the impact of excipient removal, if they are extracting the therapeutic moiety from the drug product for comparability analysis (routinely done by biosimilar manufacturers)."

Journal

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

Zydus receives Mexican regulatory approval for breast cancer drug (Business Standard) - "Zydus Lifesciences announced that the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval for Mamitra, a Trastuzumab biosimilar. The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2 overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC) and advanced gastric cancer."

Approval • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

[VIRTUAL] Assessment of structural and functional comparability of biosimilar products: Trastuzumab as a case study (ACS-Fall 2021) - "The originator product, Herclon (Roche), was compared with four marketed biosimilars: Trasturel from Reliance Life Sciences, Canmab from Biocon, Vivitra from Zydus Ingenia, Hertraz from Mylan. With respect to comparability, one biosimilar exhibited signifcant diferences in multiple attributes, such as lower percentage of monomer content and main charge variant species, lower percentage of aglycosylated glycoform G0, and lower estimated potency values. Overall, the results indicated general similarity with respect to structure and function, but we found variations with respect to size heterogeneity, charge heterogeneity, and glycosylation pattern in each of the biosimilars."

Clinical

Pfizer’s Vizimpro, Cadila’s trastuzumab biosimilar enter Ecuador (GBI Health) - "According to GBI analysis, Ecuador’s National Agency for Health Regulation, Control and Surveillance (ARCSA) this month approved Pfizer (NYSE: PFE)’s tyrosine kinase inhibitor (TKI) Vizimpro (dacomitinib) and India-based Cadila (NSE: CADILAHC)’s Tartuz (trastuzumab), a biosimilar of Roche (SWX: RO)’s oncology treatment Herceptin. Vizimpro is developed against metastatic non-small cell lung cancer (NSCLC) with defective epidermal growth factor receptor (EGFR), while originator Herceptin is used to treat HER2-overexpressing breast cancer and gastric carcinoma, although ARCSA does not release indication details."

Non-US regulatory • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

[VIRTUAL] Management of early breast cancer by trastuzumab biosimilar: Insights from observational drug utilization registry (EBCC-I 2020) - "Material and This is an observational, real world drug utilization registry where data was collected for the patients eligible to receive trastuzumab biosimilar (Vivitra®, Cadila Healthcare)... Safety of trastuzumab biosimilar was found to be acceptable. Approximately 28% patient completing the recommended treatment cycles in early breast cancer with trastuzumab biosimilar points toward accessible option in out of pocket healthcare scenario such as in India. There were marked differences in incidence of observed and expected adverse events, probably because of under reporting in real world clinical practice."

Breast Cancer • Oncology • Solid Tumor

[VIRTUAL] Management of early breast cancer by trastuzumab biosimilar: Insights from observational drug utilization registry (EBCC-I 2020) - "Material and This is an observational, real world drug utilization registry where data was collected for the patients eligible to receive trastuzumab biosimilar (Vivitra®, Cadila Healthcare)... Safety of trastuzumab biosimilar was found to be acceptable. Approximately 28% patient completing the recommended treatment cycles in early breast cancer with trastuzumab biosimilar points toward accessible option in out of pocket healthcare scenario such as in India. There were marked differences in incidence of observed and expected adverse events, probably because of under reporting in real world clinical practice."

Breast Cancer • Oncology • Solid Tumor

Zydus Cadila launches copy of Roche’s breast cancer drug Herceptin (indiainfoline) - "Zydus Cadila has launched breast cancer drug in India under the brand Vivitra - a copy of...Roche's product Herceptin...Each vial of Vivitra is priced at INR 64,999 while other Trastuzumab brands are sold in India at ~Rs. 50,000."

Biosimilar launch • Pricing • Biosimilar

Assessment of Structural and Functional Comparability of Biosimilar Products: Trastuzumab as a Case Study. (PubMed, BioDrugs) - "Overall, the results indicated general similarity with respect to structure and function, but we found variations with respect to size heterogeneity, charge heterogeneity, and glycosylation pattern in each of the biosimilars."

Clinical • Journal