TrastuRel (trastuzumab biosimilar) / Reliance Life Sci - 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

Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis. (PubMed, Immunopharmacol Immunotoxicol) - "The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3...Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients."

Journal • Retrospective data • Review • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

[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

[VIRTUAL] RAPID REVIEW OF TRASTUZUMAB BIOSIMILARS COMPARED TO REFERENCE TRASTUZUMAB FOR BREAST CANCER TREATMENT IN NAIVE PATIENTS (ISPOR 2020) - "RESULTS : We found four papers from three equivalence randomized clinical trials and one non-inferiority trial comparing four trastuzumab biosimilars (SB3, ABP 980, CT-P6 and R-TPR-016) with the reference biological drug. CONCLUSIONS : The evidence was inconclusive regarding the statistical equivalence of efficacy between trastuzumab biosimilars and their reference. On the other hand, safety proved comparable."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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